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Generic biotech drugs won't be in new drug-safety legislation
Posted: 20 September 2007
Senior lawmakers considering new drug-safety legislation have decided not to include a measure allowing cheaper copies of biotech medications after the measure met opposition from House members, says a recent article at Bloomberg.com. The drug-safety legislation is expected to be considered by the US Congress later this month.
The provision on generics is "off the table," Michael Mahaffey, a spokesman for the Senate health committee Republicans, said in an interview with Bloomberg. "There's a widespread general agreement that's something they'd take up another time."
Generic versions of conventional drugs made through chemical synthesis are regularly approved by FDA, however current law does not allow the routine approval of copies of biotech drugs. Biotech companies say their complex products cannot be simply copied without risking dangerous side effects. Read the article
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European Commission seeks extra funding for "Eurostars"
Posted: 20 September 2007
The European Commission hopes to raise €800m in extra funds for research-performing small and medium-sized enterprises (SMEs) across Europe, through a new program called Eurostars, says a recent article by DrugResearcher According to this article, Eurostars is designed to finance new partnerships between research and development (R&D) SMEs and the 27 EU Member States. Commissioner Janez Potočnik is quoted in the article. "Creating strong links between public and private funding, Eurostars will give a boost to R&D performing SMEs, allowing them to collaborate with the best research teams in Europe, and to transform new ideas into successful businesses," says Potočnik.
The EC will contribute €100m to the program with an additional €300m invested by the countries themselves. According to the EC, this will eventually mobilize up to €400m in extra private funding. The EC's goal is to make participating countries pool their national research funding in favor of SMEs, which they believe will result in more efficient use of funds.
According to DrugReseacher, "SMEs represent 99 percent of all enterprises in Europe and their small size, flexible organisation and commitment to research allows them to take advantage of a fast-changing economic environment, seize new market opportunities and create new jobs." Read the article
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FDARA likely to have major impact on drug development
Posted 20 September 2007
The Food and Drug Administration Revitalization Act (FDARA) is likely to drastically change both the manner in which companies seek FDA approval as well as support marketed products with further research, according to a recent article. FDARA is a "once-in-forty-years" overhaul of FDAauthority, says Cole Werble in The RPM Report. According to this article, the act will bring the FDA's drug safety activities "back up to par with the agency's focus on drug efficacy."
Separate versions of the act were passed by the House and Senate during the last four months and are currently being forged into one bill in pre-conference discussions. During a 12 September briefing on drug safety in Washington, DC, former FDA commissioners pointed out two major changes they saw resulting from FDARA.
The first of these involves Phase IV, strategic research. The new public-private postmarketing surveillance project featured in FDARAA will change the dominance of Phase IV by drug sponsors, says Mark McClellan, MD, who was the first FDA commissioner in the George W. Bush administration (2002-2004). The "postmarketing period will move out of the control of the pharmaceutical industry," says McClellan.
The second fundamental change involves "faster NDA/BLA approvals for narrow, precise indications." According to David Kessler, MD, FDARA offers "a form of tighter safety controls through risk management plans and postmarketing surveillance that could represent a new version of conditional approval." Kessler was FDA commissioner under George H.W. Bush and Clinton (1990-1997). Read the article
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China's first center for food and drug safety officially open
Posted: 20 September 2007
China's first center for food and drug safety officially opened 28 August. Shanghai's new Safety Research Center for Food and Drugs will focus on research regarding food and drug safety policies, as well as the administration's supervision mechanism, says a recent PharmAsia News article. The article interviewed Chen Yizhen, superintendent of the Shanghai Food and Drug Administration (FDA) Science and Technology Information Institution and deputy director of Shanghai FDA. Chen states that every year hundreds of research projects are carried out by different FDA departments. The new research center has been established to manage this research and solve problems in a more efficient manner.
The new research center will, according to Chen, provide "a platform to conduct further research on governmental policies and consolidate all the loose research conducted previously," says PharmAsia News.
Shanghai has four other FDA institutions in addition to the new research center. The other four institutions include three inspection institutions and one evaluation institution. The new research center will "focus research on the policies and supervision administration, while the other institutions will focus on the technologies and methods used during the inspection and supervision," says Zhang Renwei, a doctor at the research center. Read the article
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FDA and Gene Logic to collaborate on standards for genomics
Posted: 20 September 2007
FDA and Gene Logic will collaborate to share quality control methods and metrics for genomic data submissions to the agency. Because there are currently no federal or industry standards for genomic data assessment, the purpose of this collaboration is to develop a set of standards for genomic data sent to the regulator, according to a recent DrugResearcher article.
"Currently there are no industry standards in place for microarray data submission to the FDA, and projects focused on understanding the QC issues will help drive the development of baseline standards for the submission of microarray data to the FDA in the future," a senior FDA official is quoted in the article saying.
The collaboration is a part of FDA's Critical Path Initiative, an effort to stimulate the use of new scientific and technical methods, intended to "improve the predictability and efficiency of drug development from laboratory concept to commercially approved medicines," says BusinessWire. The results of the collaboration will be released publicly as an initial step towards formulating industry-wide standards for genomic data submissions to FDA. Read the article
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China announces pharma reforms
Posted: 13 September 2007
In a continuing effort to improve its pharmaceutical industry, China's State Food and Drug Administration (SFDA) has announced target areas of reform, which include both increasing the number of staff at injectable drug products production sites and tightening regulations on wholesalers and distributors of pharmaceutical ingredients, says a recent article at BioPharma Reporter.
SFDA plans to emphasize scrutiny on parenteral drug manufacturing. "Injectable drugs are particularly sensitive to contamination and carry greater safety risks than drugs delivered by other methods and so the agency said it plans to take particular care to ensure that the formulation and ingredients and production techniques for these drugs adhere to good manufacturing practice (GMP)," reports BioPharma Reporter.
The agency will also review the licenses of any pharmaceutical ingredient wholesaler or distributor that began operating in 2006, carefully monitoring those supplying highly restricted substances. In addition, SFDA will conduct on-site inspections of all drug products for which marketing applications were submitted and/or approved between January and August 2006. Read the article
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US panel urges "fundamental change" in import monitoring
Posted: 13 September 2007
A US panel on import safety has called for a "fundamental change" in import monitoring. These proposed changes, proposed by the Bush Administration panel, urge government agencies into greater collaboration on monitoring the riskiest products, according to The Washington Post.
The panel, headed by Health and Human Services Secretary Michael Leavitt, produced a 22-page report that "identified deficiencies including 'siloed systems, ' -- in which the various federal and state agencies used computers and other automated systems that were not integrated and could not share data," reported The Washington Post. The article reports that the main parts of the new strategy are "to ensure U.S. government agencies who share authority over food safety collaborate and use interoperable computers; to boost accountability, enforcement and deterrence; and to promote the use of the newest technologies and science"
The panel also recommended implementation of the 2006 Security and Accountability for Every Port Act, requiring all 34 federal agencies with authority over imports to build a "single window" check system by 2009. The report is currently undergoing a 60-day review period. Read the article
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Hybrid embryo research allowed in UK
Posted: 13 September 2007
UK's Human Fertilisation and Embryology Authority (HFEA) has agreed to allow Cytoplasmic Hybrid research there on a case-by-case basis, approving—but tightly regulating—the research. Moving forward eight months after debate on whether or not to allow the research began, HEFA's decision specified that all planned research project must first be deemed "necessary and desirable" before being authorized, says Drug Researcher.
"This is not a total green light for cytoplasmic hybrid research, but recognition that this area of research can, with caution and careful scrutiny, be permitted," said a HFEA, statement. "Individual research teams should be able to undertake research projects involving the creation of cytoplasmic hybrid embryos if they can demonstrate, to the satisfaction of an HFEA license committee, that their planned research project is both necessary and desirable… [as well as being] likely to lead to scientific or medical advancements."
According to Drug Researcher, "The real need for such research is the shortage of human embryos left over from fertility treatments, from which stem cells can be generated." Read the article
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No serious problems in tissue recovery industry
Posted: 13: September 2007
A study to evaluate how well the tissue recovery industry follows FDA regulations found no serious problems, according to a report by the agency's Human Tissue Task Force (HTTF). Providing human tissue for transplants is a growing and increasingly complex industry. The HTTF was set up in August 2006. According to a recent article in Medical News Today, last year's discovery of two companies that were breaching regulations and potentially putting recipients at risk prompted the study. However, earlier this year, FDA's Office of Regulatory Affairs (ORA), "carried out a 'blitz' inspection of 153 major human tissue recovery companies between last October and March this year. They found some minor irregularities but none that would put transplant recipients at risk."
According to Medical News Today, "The HTTF's report makes several recommendations for tightening up compliance to the new regulations, help the agency better understand what is going on, and develop guides and plan future inspections." Read the article
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Biotech industry among those most affected by new US patent rules
Posted: 6 September 2007
New rules being implemented by the US Patent and Trademark Office will have an adverse effect on biotechnology companies seeking to protect their inventions, says FDAlegislativewatch.com. Currently, applicants are able to file an unlimited number of patent continuation applications. However, the new rules will limit the number of continuation and continuation-in-part applications an inventor can submit. Applicants who submit more than the proscribed number of any of these applications will also need to document why the information could not have been included in an earlier submission.
Patent applicants will be allowed to submit two continuation or continuation-in-part applications, and also be limited to one request for continued examination of a patent. According to FDAlegislativewatch.com, "Since biotech companies file the largest number of these applications, which add new claims or disclosures to an original application, they will be among those most affected by the new policy." Read the article
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Pseudoephedrine drugs retain their OTC status in UK
Posted: 6 September 2007
Despite tighter controls on cold and flu remedies containing pseudoephedrine and ephedrine by UK's Medicines and Healthcare products Regulatory Agency (MHRA), the drugs will still retain their over-the-counter (OTC) status in UK. Earlier this year, health authorities consid, ered tackling the problem of OTC ephedrine- and pseudoephedrine-based drugs being used in the production of the Class A controlled drug methylamphetamine (crystal meth), by reclassifying them as prescription-only. However, according to in-Pharmatechnologist.com, "A decision to reclassify to prescription-only was described by pharmaceutical industry professionals at the time as a "disproportionate response to the problem" and could have a variety of impacts, including a drive by manufacturers to reformulate products to stay in the OTC game, which could be an expensive and risky process." The MHRA has decided to retain the OTC status of these drugs, with the following amendments: package sizes will be restricted, there will be an imposed limit of one pack per customer, and a recommendation that sales of the drugs be limited to pharmacists, says in-Pharmatechnologist. "The MHRA also announced the legal status of the products would be reclassified to prescription-only in July 2009 if the current measures to be implemented did not control the risk that the drugs could be misused." Read the article
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Study reveals no increased death risk with drug-coated stents
Posted: 6 September 2007
After evaluating the health risks of drug-coated stents, researchers at Sweden's Uppsala Clinical Centre concluded the devices are not dangerous to patients, but should be used selectively.
The new research was conducted in response to major concerns raised last year suggesting that patients treated with the stents were more likely to develop potentially fatal blood clots months or years after their surgery.
According to CNNMoney.com, the recent follow-up study does not indicate, "an increased risk of death compared with bare-metal stents," but it does suggest that "the benefits of these devices are limited and that the risk of developing blood clots remains." Read the article
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First individual human genome decoded
Posted: 6 September 2007
Dr. J Craig Venter's research team recently announced it has decoded a new version of the human genome. Some experts believe this new genome is an improvement over the human genome project completed in 2003 by a government-financed consortium of academic centers. "The consortium's genome, thought immensely useful to biologists," says the New York Times, "was full of gaps and only complete in the sense that it was the best that could be done with existing technology." According to a recent Agence France-Presse(AFP) article, the earlier efforts at decoding the human genome "were flawed and greatly underestimated genetic diversity…because the whole had been assembled from a hodgepodge of DNA taken from several individuals."
The main difference between the consortium's genome and Venter's, says the New York Times article, is that the consortium project came from a group of people from different racial and ethnic backgrounds and comprised only half the DNA contained in a normal cell, while Venter's research reveals the first individual genome ever sequenced—his own. "Venter's research indicates that in 44% of Venter's genes, the copies from his mother differ from those inherited from his father," the article says. These findings overturn a previous assumption in the scientific community that all human begins are 99.9% identical.
The research has sparked some controversy among ethicists who question the possible abuses that may occur once the coding of individual genomes makes personal health information more easily accessible. Venter, however, believes the benefits outweigh the risks, and that the information provided will be at most only an indicator of risk. "The genome is far from perfect," says CNN, "[Venter] doesn't see it as an absolute, but rather as a clue. It's an indicator of risk, but not a certainty. For example, Venter has a normal risk for skin cancer, but still he recently battled melanoma." Read the article
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Drug launches must localize to find global success
Posted: 30 August 2007
New research indicates that pharmaceutical companies that customize the promotion of new drugs to the nuances of individual countries have greater success on a global scale than companies that do not adapt to local markets. IMS Health, a Connecticut-based research firm, recently examined 4,225 drug launches in an effort to better understand what it takes for a pharmaceutical company's drug launch to be successful on a global scale. Of the 4,225 drug launches, only 35 managed to become first or second market leaders within two years, in two or more countries, says CNNMoney.com. The research indicates that to achieve a successful launch of a blockbuster drug, "the sales force must understand the nuances of different countries and customize its promotion to match international health plans."
According to CNN Money, the IMS Health study identified the most successful drug launches of all time as: Pfizer Inc.'s cholesterol-lowering Lipitor and sexual dysfunction drug Viagra, GlaxoSmithKline's diabetes treatment Avandia, Eli Lilly & Co.'s anti-psychotic Zyprexa and Merck & Co. Inc.'s osteoporosis drug Fosamax. According to the same study, raising awareness in doctors and patients is essential to a drug's success, "These drugs took over various markets by making them bigger, not just by taking over market share in stagnant industries," the article states. Read the article
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European Commission wants more info about nanotech
Posted: 30 August 2007
The European Commission's 2006 report on the potential health risks of nanotechnologies has been rewritten at the request of the EC in an effort to make the subject more understandable for both the food industry and the public. The original report stated that new risk assessment methods are needed to assess the properties of nanoparticles. Greenfacts, which specializes in making scientific reports comprehensible to laymen, told Food Productions Daily that, "the original document was written for scientists. We have rewritten it to bring the subject into a wider domain."
The EC requested the rewrite after the original report's summary indicated that industry players and consumers need to better understand the subject of nanotechnology because it will have a giant impact upon the food industry. According to Nutraingredients.com, in a report published last month, "the consultancy Helmut Kaiser said that the nanotechnology food packaging industry could be worth as much as €22bn ($30bn), based on current market value estimates, while some estimates said the market could be worth €740bn ($1tn) by 2013."
Nanotechnologies are currently being used by the food industry to improve , the quality of packaging materials; however, "The report stated that new risk assessment methods are needed because chemicals in their nanoparticle form have potentially very different properties than their larger physical forms," says Nutraingredients.com. The original report by the EC, Themodified Opinion (after public consultation) on the appropriateness of existing methodologies to assess the potential risks associated with engineered and adventitious products of nanotechnologies, claims more research is needed about the potential human health risks of nontechnologies. Read the article
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FDA considers outsourcing some jobs
Posted: 30 August 2007
A decision is expected next month as to whether FDA will outsource hundreds of jobs to private companies. A recent Washington Post article indicates that FDA is reviews over 300 positions, "to determine whether could be performed cheaper and better by the private sector."
The National Treasury Employees Union is urging Congress to oppose the agency's plan. Colleen Kelly, the union's president, is quoted in the article saying, "It is a disgrace given the recent crises we experienced with our food supply and other imports."
FDA spokesman Chris Kelly told Washington Post that only administrative jobs not directly involved in food-safety inspections are under review. These jobs are classified as "commercial" and do not have to be performed by government employees." Read the article
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First US based cell-derived flu vaccine plant being constructed
Posted: 30 August 2007
The first ever cell culture-derived flu vaccine plant in the United States is currently being constructed in North Carolina. The Novartis manufacturing facility, expected to be completed in 2009 with initial vaccine production in 2011, will be capable of producing 50 million doses of seasonal trivalent flu vaccine and up to 150m doses of monovalent vaccine.
Novartis' investment in the site was funded in part by a 2006 multi-million dollar grant from the US Department of Health and Human Services (HHS), says DrugResearcher.com, "The HHS's aim is to be able to domestically produce 600 million doses of flu vaccine within six months of a pandemic outbreak declaration - a quarter of which could come from the Novartis facility."
According to a recent DrugReseacher.com article, cell-based systems like the one being constructed by Novartis may be the potential future of vaccine manufacturing, "shunning the traditional yet cumbersome egg-based manufacturing techniques."
According to the Center for Infectious Disease Research & Policy (CIDRAP), HHS cited several advantages of using cell-culture technology instead of egg-based to make flu vaccines: "Viruses don't need to be adapted to grow in eggs, and manufacturers can freeze cells in advance and then thaw and grow them in large volumes in the event of a shortage or pandemic. Also, the method is safe from certain risks associated with egg-based production, such as the chance of eggs being contaminated by various poultry diseases. Finally, cell-based vaccines could be used by people who can't receive the currently licensed vaccines because they are allergic to eggs." Read the article
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FDA proposes new rating system for sunscreens
Posted: 30 August 2007
FDA has proposed a new rating system for alerting consumers about a sunscreen's effectiveness in blocking UVA rays. FDA says this is necessary because most commercial sunscreens currently screen out only ultraviolet B (UVB), overlooking the fact that ultraviolet A (UVA) also increases skin cancer risks and skin aging. The new rating system would alert consumers about a sunscreen's effectiveness in blocking both forms of UVA rays.
According to a recent Washington Post article, "The agency has long been looking into making recommendations on UVA protection, Dr. Douglas C. Throckmorton, the deputy director of FDA's Center for Drug Evaluation and Research, said during a mid-afternoon teleconference. Only now has the agency settled on which tests it will accept for rating UVA protection, he said."
The new system is now undergoing a 90-day public comment period before being published. The appearance of any new labeling is not expected to occur until 2009 at the earliest. Read the article
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Poland trying to increase market potential for trials
Posted: 23 August 2007
Poland's clinical trials market is expected to grow 10-12% this year, says Polish market research firm PMR, according to in-Pharmatechnologist. For the past few years, pharmaceutical companies have been gradually moving toward conducting clinical trials in emerging markets, rather than in Western Europe and the US. Central Eastern European Countries like Russia and Poland are becoming increasingly attractive emerging markets, "with relatively close proximities to the West, along with treatment-naïve populations of a Caucasian gene pool," says in-Pharmatechnologist.
While Poland holds potential, "excessive red-tape, bureaucratic chaos and no standardized requirements for trial documentation," were commonly listed as concerns in the PMR study. The most commonly cited deterrent is Poland's "cumbersome process for registering a trail with the Central Register of Clinical Trials (CEBK)."
However, the article indicates CEBK has since taken steps to streamline and simplify the registration process: "One particular improvement in the legislation, according to PMR, is the fact that clinical trial applicants will not be obliged to submit copies of contracts confirmed by a notary, which were dubbed by survey participants as an 'unnecessary bureaucracy.'" Read the article
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Report examines decrease in FDA drug approvals
Posted: 23 August 2007
FDA has been increasingly reluctant to approve new drugs, according to a report on the decline of new product approvals in the pharmaceutical industry. "FDA has been pretty much playing defensive since 2004," says James Krumpel, analyst for Friedman, Billings, Ramsey, in a recent CNNMoney.com article. According to Krumpel, this defensive stance is the result of FDA's approval of arthritis painkiller Vioxx, which was pulled from the market in 2004 when studies indicated a link between the drug and an increased risk of heart attack or stroke.
According to Krumpel, FDA approved 38 new drugs from January through July of this year, "down 31% from 55 approvals during the same period in 2006." Additionally, of this year's approved products, only seven can be considered completely new, "which is a ten-year low for the industry."
In an email to CNNMoney.com, FDA spokeswoman Susan Cruzan denied allegations that the agency is being tougher on drug applications. "There have been no systematic changes in how we are approaching the approval standards for new applications," Cruzan said, "each application is reviewed on it's own merit." Read the article
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European pharma contributes to US vaccine supply
Posted: 23 August 2007
The US will be receiving its largest influenza vaccine supply ever, says in-Pharmatechnologist, with an estimated 130 million doses of the vaccine. Two European vaccine manufacturers, Novartis and Sanofi Pasteur, are contributing 90 million doses. The remaining 40 million will be supplied by GlaxoSmithKline and MedImmune.
According to the US Centers for Disease Control and Prevention, the primary months for influenza vaccinations are October and November. Novartis will supply 40 million doses to the US by the end of October. Of these, 20 million will be shipped by the end of September. Sanofi Pasteur plans to make 50 million doses available by the end of October.
The 130 million doses of vaccine is the largest supply in US history. However, according to in-Pharmatechnologist, "Despite the largest vaccine stash so far, the US will still have a shortfall in the amount of vaccine. US recommendations state 220 million people should be vaccinated against the disease." The article states that influenza is responsible for more than 200,000 hospitalizations and kills approximately 36,000 people in the US annually. Read the article
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Drug ad monitoring change
Posted: 23 August 2007
Direct-to-consumer pharmaceutical advertisements in the US grew to $29.9 billion in 2005, up from $11.4 billion in 1996, representing an average annual growth rate of 10.6%, says a study in a recent New England Journal of Medicine. However, "the researchers also found that regulators are doing less to police such ads," says MSNBC in a recent article.
Julie Donohue, of the University of Pittsburgh Graduate School of Public Health, conducted this study. Donohue and her colleagues looked at industry data from three market research firms that track advertising spending. According to MSNBC, the group found that, "FDA has been sending out fewer letters to drug companies warning them that their commercials are minimizing risks or exaggerating effectiveness." In 1997, FDA sent out 142 letters, while last year there were only 21. Additionally, while "64% of the ads broadcast on television in 1999 were reviewed by the FDA, the ratio had declined to 32% by 2004," the article says. Read the article
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Outsourcing trends may be shifting from manufacturing to clinical trials
Posted: 16 August 2007
A new report indicates that major pharmaceutical companies are starting to focus more attention on the outsourcing of clinical research rather than outsourcing manufacturing operations, says a recent In-Pharmatechnologist article. Pricewaterhouse Coopers interviewed 185 senior pharmaceutical executives from both global and Asian companies. The results indicate that 72% of multinational companies are considering outsourcing clinical trials to Asia, 39% of companies surveyed are currently considering hiring Asian service providers for manufacturing small molecules, and only 20% are considering this option to make their protein-based products.The two Asian countries currently in the highest demand are China and India. According to the same article, "Both countries are making efforts to be more transparent in terms of the conduction of clinical trials and both have recently joined the World Health Organization's (WHO) clinical registry platform which now includes trial registers from China and India." Read the article
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EU warns Thais on drug prices
Posted: 16 August 2007
European Union Trade Commissioner Peter Mandelson recently warned the Thai government against its consideration of a broad use of compulsory licenses that will allow the country to import cheaper generic versions of branded medicines, says TheFinancial Times. In a letter, seen by The Financial Times, Mandelson says that Thailand's military government has stated that if drug companies wish to do business in Thailand, "they should offer their drugs for no more than five percent above the generic cost."
Mandelson states: "This approach is a matter of concern for the European Union and would be detrimental to the patent system, and so to innovation and the development of new medicines." He also encouraged Bangkok to negotiate with a pharmaceutical company over a drug for heart disease having been supplanted by cheaper Indian imports.
The Financial Times says, "Mr. Mandelson's tough language will antagonize the European parliament, . His letter , , was written in July just days before Members of the European Parliament (MEPs) from all parties called on the EU to back more flexible compulsory licensing rules at the WTO." An earlier, 3 July, Financial Times article claimed that MEPs from the six main groups in parliament had been seeking more flexible licensing rules in an effort to fund the creation of a generic drugs industry in poorer countries "as the long-term solution to the developing world's health crises." Read the article
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Court refuses terminally ill patients access to experimental drugs
Posted: 16 August 2007
The US Court of Appeals for the District of Columbia Circuit has overturned last year's district court decision, thus preventing terminally ill patients' access to potentially lifesaving drugs. "Terminally ill patients do not have a constitutional right to be treated with experimental drugs," says Matt Appuzzo of the Associated Press, in reference to the recent ruling. This ruling was the result of case brought against the court by the Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation.
According to a recent News-Medical.net article, after initial safety tests FDA "demands comprehensive research be conducted in both the laboratory and on animals before advanced trials with people are carried out"—a process that can take as long as 10 years before a new drug is approved. The Abigail Alliance argues, however, that patients should have a constitutional right to try experimental drugs that have passed the initial safety tests, but have not gained final approval.
The same article states: "Judge Thomas Griffith said the FDA's policy of limiting access to investigational drugs is rationally related to the legitimate state interest of protecting patients, including the terminally ill, from potentially unsafe drugs with unknown therapeutic effects." Read the article
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EMEA to Update GMP Guide
Posted: 16 August 2007
EMEA plans to update Chapter 5 of its GMP Guide in an effort to ensure that various active substances and starting materials are manufactured according to good manufacturing practices (GMPs). In a recent FDANews bulletin, EMEA is quoted saying, "Although [Chapter 5] does provide some guidance on the qualification of suppliers, it does not emphasize the obligation to ensure that active substances are produced in accordance with GMP."
The consultation will be released in late September and the deadline for comments is March 2008, under EMEA's Ad Hoc GMP Inspection Services Group's (GISG) proposed timetable for publication. Read the article
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European Commission addresses pharma challenges
Posted: 9 August 2007
In a consultation on the future of pharmaceuticals for human use in Europe, the European Commission has highlighted three major challenges impacting its pharmaceutical sector, says Newsfood.com in a recent article. These challenges are: the globalization of the sector; the smooth functioning of the internal market; and advances in science and technology.
Regarding globalization, the article quotes the Commission as saying: "The centre of gravity for worldwide R&D [research and development] investment in the field is gradually moving to the United States and Asia." Addressing the internal market, the Commission asserts, "the challenge is thus to strengthen and rationalize drug safety monitoring, while avoiding unnecessary requirements that would impair patient's access to treatments." Additionally, the Commission identified several advances and concerns related to emerging sciences and technology. These include such areas as: regenerative medicine; more personalized treatments; and the development of nanomedicines.
According to the same article: "Key questions asked by the Commission concern other challenges to the industry, such as what measure could be implemented to ensure the safety of medicines supplied to the EU, how to improve Europe's international competitiveness and how the EU regulatory framework can be applied to emerging technologies." Read the article
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US House passes drug import bill
Posted: 9 August 2007
The US House of Representatives recently passed legislation that will permit importation of prescription drugs from other countries, such as Canada, Australia and European nations, where they are often lower in cost. The bill passed by a vote of 237-18 and now faces a promised veto from President Bush.
According to the Associated Press: "T, he administration 'strongly opposes' the drug provision, which would effectively permit individuals, wholesalers and pharmacists to import lower cost U.S.-made and FDA-approved prescription drugs from Canada and other countries."
This same article quotes Rep. Mike Rogers, R-Mich, who explains the administration's opposition as an effort to protect consumers from counterfeit or unsafe drugs. "What we're doing is throwing open the gates to every [drug] counterfeiter in the world," says Rogers.
Currently the United States has the highest prices for brand-name drugs. Read the article
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First China MRI training center established
Posted: 9 August 2007
A healthcare company recently co-founded China's first MR Application Academy, in an effort to rectify a shortage of trained professionals in magnetic resonance imaging. The academy, started in part by GE Healthcare, will be located at its GE China Technology Center in Shanghai.
AHC Newsletters quotes George Cao, general manager-marketing, GE Healthcare China as saying: "As medical reform in China continues, GE Healthcare will maintain its support of the academy in order to cultivate a world-class pool of senior MRI experts to meet China's needs within the next five to 10 years."
According to this article, hospitals in China suffer from a shortage of technicians, physicists and radiologists specializing in MR imaging, while the use of MRI in China is expected to escalate. More than 2,000 MRI units have been deployed across China, GE has said, while the ratio of equipment to population is "25 times less than the U.S. Market. Read the article
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Court orders UK to review animal testing
Posted: 3 August 2007
A court has ruled that UK's Home Office must review the assessment system it uses for animal experiments, in an effort to lesson any suffering that may occur during animal experimentation. The British Union for the Abolition of Vivisection (BUAV) conducted a ten month undercover investigation at Cambridge University's primate research facility, between 2000 and 2001, before bringing the case against UK's Home Office.
According to in-Pharmatechnologist: "The investigation revealed that at this facility, marmoset endured highly invasive brain surgery - sometimes with either no or very minimal painkillers. In addition, it challenged the Home Office's label of 'moderate' suffering to experiments that contained highly invasive procedures, including inducing strokes by removing the top of marmosets' heads."
Last week, a judge agreed with the BUAV and ordered the Home Office to undertake a review into its processes. However, the ruling does not strictly necessitate any changes will need to be made. In addition, the Home Office retains the right to appeal the decision. Read the article
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Dietary supplement cGMPs compliance nears
Posted: 3 August 2007
US FDA's final ruling on dietary supplements' current Good Manufacturing Practices (cGMPs) will take effect later this month, and some companies are struggling to achieve compliance. FDA released the final ruling on the cGMPs in mid-June, in an effort to improve quality in the dietary supplement industry. The final rule is effective 24 August 2007. It will apply to companies that manufacture, package or store dietary supplements, compelling them to further evaluate the identity, purity, strength and composition of their dietary supplements.
According to a recent article in Natural Products Insider, in an economic analysis section of the new regulation that outlines the estimated costs companies of various sizes might occur in complying with the GMP rule, "FDA estimated 140 very small and 32 small dietary supplement manufacturers will be at risk of going out of business."
Since the release of the final rule, several third-party consulting companies have emerged to help manufacturers and other companies achieve compliance with the new regulations. Read the article
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FDA says nanotech presents challenges
Posted: 3 August 2007
FDA recently identified issues stemming from the use of nanotechnology in regulated healthcare products, and senior FDA staff said they see nano-related challenges with every product they regulate. The statements took place at a briefing last week that followed FDA' release of the first report from its Nanotechnology Task Force. The report highlighted the agency's regulatory approach toward nanotechnology and discussed the ways in which nanotechnology impacts areas of FDA responsibility.
A recent Science Daily article quotes David Rejeski, the Project on Emerging Nanotechnologies Director: "Today, there are more than 500 manufacturers identified nanotechnology consumer products being sold," and that, "In light of this fast-rising commercialization, FDA needs to make certain that it has the tools, resources and information necessary to ensure the safety of novel products before they enter the market, and to detect and move swiftly to correct any problems that may arise."
The Wilson Center's Project on Emerging Nanotechnologies maintains an online inventory of the products at http://www.nanotechproject.org/consumerproducts. Additionally, an in-depth analysis of FDA's nanotechnology readiness, commissioned by the Project on Emerging Nanotechnologies, is currently available at http://www.nanotechproject.org/82. Read the article
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Devices attracting venture capitalists
Posted: 3 August 2007
The US medical devices industry has seen a 58% increase in venture capitalist investments since the second quarter of 2006. According to industry data released Monday, $1 billion have been committed to developers of medical device therapies.
"It was the ninth consecutive quarter of year-over-year growth in the amount of venture capital invested," says the Associated Press. According to the same article, one reason for this significant increase in industry investments is because, "increasingly venture firms see opportunity to displace drugs, which often work in only a small portion of patients, with devices that are effective in nearly everyone." Read the article
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Patent reform bills considered by US House and Senate
Posted: 26 July 2007
New patent reform bills now before Congress, would make the most extensive changes to patent law in more than 50 years. The Senate Judiciary Committee approved a patent reform bill last Thursday that seeks to improve patent quality and reduce the number of costly infringement lawsuits. The House Judiciary Panel cleared a similar bill last Wednesday.
According to The Washington Post, the new legislation will "make it harder to secure a patent and easier to challenge one, and it would change how courts determine an infringed patent's values."
So far the bills have been supported by the IT sector and opposed by the pharmaceutical and biotechnology industries. According to The Washington Post, software and technology companies argue "their complex products with hundreds of patents makes them easy targets for , patent infringement suits based on inadvertent or minor violations." The Biotech Industry Organization opposes the bill, claiming it "threatens continued biotech innovation."
Both bills will now need to be considered by the full House and Senate. Read the article
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Cannabis-based MS treatment stalled in UK
Posted: 26 July 2007
GW Pharmaceuticals has decided to pull an EU application for a cannabis-derived multiple sclerosis (MS) treatment so it can fulfill requests for additional data by the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The company pulled the application for Sativex in response to demands by UK regulators for additional data. According to Drugresearcher.com, the regulators requested more data because Sativex is intended for patients who have exhausted all other treatment options, "which means that some subjects simply lack the ability to respond to the drug, or any other MS treatment."
MHRA has requested an "enriched design" study, says Drugresearcher.com, specifically focusing on patients who respond to the treatment, despite the fact that "there are no quality or safety issues standing in the way of approval" for GW's spasticity treatment Sativex and clinical efficacy data shows "promising and statistically significant results." GW has already anticipated conducting the type of study required. The first patients will be able to enter trial as soon as October of this year. Trial completion is expected in approximately 12 months. Read the article
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Registration of clinical trials in India now mandatory
Posted: 26 July 2007
The Indian Council of Medical Research launched the official Clinical Trial Registry of India (CTRI) on 20 July. All clinical trials conducted in India will now have to register in the CTRI before enrolling the first human participant. According to The Times of India, "the health ministry has been urging drug firms and research bodies to register all medical studies on humans from the outset." However, before the CTRI, researchers could opt to wait until they were well advanced in their work before reporting on the results. India is becoming an increasingly attractive destination for clinical research. Read the article
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US Senate Committee favors biogenerics
Posted: 26 July 2007
A US Senate committee recently voted in favor of legislation that would allow FDA to approve biogeneric drugs. Currently, FDA lacks a clear regulatory pathway to approve follow-on biologics, or "biogenerics." No biogeneric products have been approved in the US because of this inability for FDA to regulate. However, that may no longer be the case. , The bill The Biologics Price Competition and Innovation Act of 2007 will, according to Drug Week, address the "scientific, regulatory and legal issues involved in bringing affordable biologics to the marketplace."
Some biotechnology firms oppose the bill, claiming that biogenerics legislation could undermine innovation and that their products are too difficult to copy without risking dangerous side effects. Those in favor of the legislation focus on the lower prices that will come with biogeneric products. Read the article
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New pediatric committee meets
Posted: 19 July 2007
The new Paediatric Committee (PDCO) for the European Medicines Agency (EMEA) recently held its first meeting. The meeting, held earlier this month in London, was "devoted to preparing the groundwork for the Committee's future activities, and included discussion of the following topics: scientific and procedural aspects for the assessment of paediatric investigation plans (PIPs); the EMEA implementation strategy for an EU-wide paediatric-research network; a recommendation to the European Commission on the selection of a symbol for medicines with a paediatric indication; criteria for a survey of existing uses of medicinal products in the paediatric population in the EU; funding of studies into off-patent medicines provided by the EU's Seventh Framework Programme (FP7)." According to Medicalnewstoday.com, "the PDCO's main responsibility will be to provide opinions on the development of medicines for use in children." The PDCO is part of the implementation of new Paediatric Regulation within EMEA. Read the article
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Senate generics bill addresses exclusivity, trials & safety
Posted: 19 July 2007
Several consumer and insurance groups have been lobbying Congress to make it easier for generic drug makers to bring copycat versions of expensive biotechnology drugs to market, says the San Diego Union-Tribune. According to a recent article, a new bipartisan Senate bill, attempting to balance consumer demands for more affordable medicine with the needs of the biotechnology industry, has already passed a key Senate committee. However, the measure has not been taken up in the House. The Senate bill addresses issues of market exclusivity, clinical trials and safety, and "seems just enough of a compromise that there's something to make people on every side of the debate unhappy." The current bill guarantees an innovative biotechnology therapy 12 years of market exclusivity, the article states. Industry, however, says it takes 14 years to recoup its investment, while consumer groups want just five years of exclusivity. Read the article
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US pharma firms conducting more research abroad
Posted: 19 July 2007
The total number of investigational new drug ( IND) applications submitted to FDA has seen its second-highest jump in the last few years, says a recent drugresearcher.com article. However, "the agency has anecdotally witnessed a simultaneous jump in the number of INDs being based upon data gathered from early-phase research conducted out the US." According to the article, before a new compound can begin clinical trials and ultimately reach the US market, it first needs to be approved as an IND by FDA. "It's also possible to obtain an IND using preclinical, Phase I and II data obtained from accredited sites from outside the US, and then begin US-based studies at a much later stage in development, and it appear that this is a route that more and more companies are now choosing." Read the article
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Growth hormones could help stroke victims
Posted: 19 July 2007
New growth hormone research at the University of Auckland shows "enormous potential" for stroke victims, says Dr. Arjan Scheepans. His research demonstrates how injecting human growth hormone into the brain, even weeks after a stroke, can lead to greatly improved recovery rates. Dr. Scheepans recently told The Australian that the research results showed great promise because, previously, "no effective treatment existed for stroke unless the victim made it to the hospital in the first two to three hours after the incident. Very few did." However, laboratory rats receiving injections of the new growth hormone treatment showed "significant improvement," even four days after the stroke. "The most exciting aspect of our breakthrough," Dr. Scheepans said, "is that it shows a positive effect when the growth hormone is given at a point in time later than those first hours." Read the article
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EU, US strengthen cooperation on devices
Posted: 12 July 2007
The European Union and United States have agreed to increase their sharing of information on the safety of cosmetics and medical devices, the Wall Street Journal reports. According to EC Vice-President Günter Verheugen, European Chairman of the Transatlantic Economic Council and Commissioner for Enterprise and Industry policy: "At this year's EU-U.S. Summit we agreed to put in place a new framework for transatlantic economic integration." Verheugen went on to say, "I'm pleased to see that our ongoing cooperation with U.S. regulators is delivering tangible results for our citizens and businesses. The EU and U.S. will be able to exchange early information to protect public health, whilst taking away stumbling blocks for trade. In the field of cosmetics, today's agreement represents an important step towards our goal of accepting each other's alternative methods to animal testing." According to Businesswire.com, "The EC and U.S. Government will from now on be able to exchange confidential information about the safety of cosmetics and medical devices." Read the article
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FDA issues health claims draft guidance
Posted: 12 July 2007
According to a recent Nutraingredients.com article, FDA has issued health claims draft guidance. The purpose of FDA's document, entitled Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims, is: "to set out FDA's current thinking on t, he process for evaluating scientific evidence for a health claim and credible scientific evidence to support a qualified health claim." According to the agency: "The draft guidance, when finalized, will represent the agency's current thinking on the scientific review process for SSA and qualified health claims." In addition, "it does not create or confer any rights for or on any person and does not operate to bind FDA or the public." Read the article
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Bioethics training focuses on Africa
Posted: 12 July 2007
According to the Johns Hopkins Gazette, the Johns Hopkins Fogarty African Research Ethics Training Program was the subject of a recent case study published in the July issue of Academic Medicine that "reveals for the first time some potent lessons in what it takes to deliver a successful cross-cultural ethics training program." In 2000, the Fogarty International Center of the NIH established the International Bioethics Education and Career Development Award to "improve the quality of international ethics training, with a special focus on training for professionals from developing countries," according to the Gazette.
Johns Hopkins was one of five institutions in North America selected to launch the initiative and selected Africa as its area of focus. Since then, three to five scientists from sub-Saharan Africa have participated each year. According to Adnan Hyder, the program's co-director and an associate professor of international health at the Johns Hopkins Bloomberg School of Public Health, the program, "attempts to mitigate a familiar problem for researchers in Africa: trying to borrow principles of ethical review from developed countries. Instead, trainees contribute to the research ethics capacity of their home country by setting the agenda themselves. The process transforms students into effective researchers and advocates for the kind of research ethics that will actually work in their own countries." Read the article
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Synthetic biology shows promise
Posted: 12 July 2007
Synthetic biology, according The New York Times, involves an effort by engineers to "rewire the genetic circuitry of living organisms." According to this article, synthetic biologists identify networks of useful genes on their computer screens by downloading the gene sequences filed in DNA data banks. The longest piece of DNA synthesized so far has been 35,000 units long. However, scientists at the J. Craig Venter Institute in Rockville, MD, "hope to take a giant stride in synthetic biology by creating a piece of DNA 580,076 units in length from simple chemicals, chiefly the material that constitutes DNA's four-letter chemical alphabet." The article state that this molecule would be an exact copy of the genome of a small bacterium: "If this man-made genome can take over the cell's functions, Venter should be able to claim he has made the first synthetic cell." Read the article (New York Times, registration required)
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Companies use old generics to make new drugs
Posted: 7 July 2007
Biotech companies are trying to find cheaper and quicker ways to develop new medicines by combining older generic drugs—which have lost their patents—to create entirely new products. According to a recent New York Times article, combination drugs are not only quicker or cheaper to develop than single new drugs but might also be more effective, "when they work, combination drugs mean fewer pills to swallow, making it easier for patients to complete a course of treatment—and, as a result, for companies to hit sales targets."
According to the same article, doctors have often used two or more drugs to treat people with various diseases, ranging from cancer and heart disease to HIV infections. It is only recently, however, that pharmaceutical companies have decided to make the, combinations themselves. The article indicates that successful combination drugs already on the market include asthma drugs and cholesterol-lowering medicines. Read the article (New York Times, registration required)
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Ireland popular with pharma
Posted: 7 July 2007
Ireland is currently enjoying increased popularity for pharmaceutical activities. According to in-Pharmatechnologist.com, numerous pharmaceutical companies—such as Pfizer, GlaxoSmithKline, Wyeth, Amgen and Abbott—have set up shop in the country. Brandon Halpin of Ireland's Industrial Development Agency (IDA) told Pharmatechnologist.com, "Fourteen of the top 15 Pharma companies are present in Ireland." Regarding Ireland's push to establish itself as prime location for pharmaceutical and biological activities, Halpin said, "the last couple years have been particularly good in terms of pharmaceutical and biotech investments." Read the article
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Brain cancer hope found in frogs
Posted: 7 July 2007
According to BBC News, "A synthetic molecule based on one found in frogs eggs could potentially be used to treat brain tumors." The article indicates that Amphinase, a molecule from egg cells of the northern leopard frog, latches onto a, "sugary coating found on a tumor cell," before invading and killing it. Researchers from the University of Bath claim this molecule has great potential in treating brain tumors. Researcher Professor Ravi Acharya told BBC, "It is highly specific at hunting and destroying tumor cells, is easily synthesized in the laboratory and offers great hope as a therapeutic treatment of the future." Because Amphinase comes from an amphibian—and not a mammal—it is better suited to evade the usual defenses of cancer cells in mammals. Read the article
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Dietary supplement GMPs released by US FDA
Posted: 7 July 2007
FDA released a final ruling on current Good Manufacturing Practices (cGMPs) for dietary supplements. According to Natural Products Insider, "This much anticipated ruling applies to companies that manufacture, package or store dietary supplements; FDA management explained, for the most part, retailers are not included on a case-by-case basis." Andrew C. van Eschenbach, M.D., Commissioner of FDA said, "This rule helps ensure the quality of dietary supplements so that consumers can be confident the products they purchase contain what is on the label." Additionally, Eschenbach said, "industry will be required to report all serious dietary supplement related adverse events to FDA."
According to an FDA press release, "The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints." GMPs have been missing for 13 years from The 1994Dietary Supplements Health and Education Act (DSHEA). Related article
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Russian pharmaceutical market set for growth
Posted: 28 June 2007
The global pharmaceutical market will more than double in value to $1.3 trillion by 2020, according to a new PricewaterhouseCoopers report published last week. Russia is among the countries where consumption of medicines is expected to grow dramatically. Read the article
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Clinical trial bill to be tabled
Posted: 28 June 2007
India 's proposed Central Drug Authority (CDA) bill, which includes strict penalties for those who violate norms of clinical trials, will be tabled during the upcoming monsoon session of the Indian Parliament. Read the article
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Commission puts forward plans for nanoelectronics JTI
Posted: 28 June 2007
The European Commission has announced a new Joint Technology Initiative (JTI) that focuses on nanoelectronics. The European Nanoelectronics Initiative Advisory Council (ENIAC) initiative will have a budget of €3 billion. Read the article
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FDA, EU, EMEA expand cooperation
Posted: 21 June 2007
The European Medicines Agency (EMEA) has agreed to expand current regulatory cooperation with the FDA and the European Commission to pediatrics and medicinal products for rare diseases ("orphan drugs"). New areas of transatlantic regulatory cooperation are also being discussed for medical devices and cosmetics. Read the article
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Low-cost drug sales from China, India strong
Posted: 21 June 2007
Eager to meet a growing US demand for lower-cost medicines, Chinese and Indian companies continue to sell increased amounts of drugs and drug ingredients to the United States. China sold more than $675 million in pharmaceutical ingredients and products in the US market last year, while nearly 350 varieties and strengths of antidepressants, heart medicines, antibiotics and other drugs purchased are made by Indian manufacturers.
The Seattle Times reports, however, that FDA quality-control inspections of manufacturing plants in India and China are relatively low. In the past seven years, FDA has conducted roughly 200 inspections of plants in India and China. FDA made 1,222 quality-assurance inspections in the United States last year alone. It conducted only a handful in India, which has more plants making drugs and drug ingredients for the US consumers than any other foreign nation. Read the article
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Researchers use nanotechnology to inject living cells
Posted: 21 June 2007
A technique utilizing nanotechnology helped researchers discover that minor changes to the intensity of specialized pulsed lasers allows them to inject individual cells while keeping healthy cell from dying. According to Nanowerk News, researchers at Rensselaer Polytechnic Institute recently analyzed the nanoscale injection process on living cells for the first time.
The discovery is of significance because human illness begins and advances at the cellular level. Previously, specialized pulsed lasers were used to inject individual cells with a variety of materials, but little was known about how this type of injection might affect living cells. Understanding how materials like proteins or drug ingredients affect an individual cell can give researchers important insights into how that material might impact the entire human body. The new finding could serve as a set of guidelines for future research that requires precise microinjection of live single cells. Such research ranges from testing drugs for toxicity to targeting tumor cells with chemotherapy. Read the article
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Legislation presents business opportunities for GMP consultants
Posted: 21 June 2007
New Good Manufacturing Practices (GMP) legislation is expected to create new business opportunities for companies that can support manufacturers looking who need to comply with the GMPs within the specified time frame to be specified. One company in particular, The Pharmaceutical Consulting Services in Phillips Ranch California, has recently announced it will begin operations by the end of June, anticipating GMP-related business. The new legislation will provide standards specific to the industry for inspectors to check for purity, safety and legality in manufacturing. These standards will in turn create new business opportunities for companies or organizations that can support manufacturers looking to upgrade or comply with GMPs within the time frame to be specified. Read the article
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FDA, EU, EMEA expand cooperation
Posted: 21 June 2007
The European Medicines Agency (EMEA) has agreed to expand current regulatory cooperation with the FDA and the European Commission to pediatrics and medicinal products for rare diseases ("orphan drugs"). New areas of transatlantic regulatory cooperation are also being discussed for medical devices and cosmetics. Read the article
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FDA says MDUFMA crucial to postmarket surveillance
Posted: 15 June 2007
A new FDA report states that the reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA) is crucial to improving postmarket surveillance of devices. The report, "Effects of the Medical Device User Fee Program on Postmarket Surveillance of Medical Devices," was sent by the agency to the House Energy and Commerce Committee following the request of a congressman. According to FDA News, the report "identified several areas where 'additional effort' is needed to ensure effective postmarket surveillance of medical devices." The report, which was originally due to Congress in January, elaborates on those areas. Read the article
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China announces more safety measures
Posted: 15 June 2007
China has announced more moves to improve drug safety, including a series of regulatory reforms and a commitment to put new controls and regulations in place by 2010. Additionally, China plans to inspect up to 80% of drugs manufactured there—a sharp rise from the 30% currently inspected. According to Lab Technologist, "China is also a source of much of the world's counterfeit drugs—another acute danger to public safety, not to mention the impact on pharma industry revenues." Read the article
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EU to have single regulation for advanced biologics
Posted: 7 June 2007
The European Parliament has passed the first reading of Regulation on Advanced Therapies, which means Europe will soon have only one regulation for advanced biologics. According to BioPharma Reporter, the regulation creates "a single legislative framework for the regulation of all therapeutic products derived from advanced cell, gene and tissue engineering techniques." The new regulation mandates a centralized marketing authorization procedure. Additionally, it requires "the establishment of an expert committee within the European Medicines Agency (EMEA) to scientifically evaluate, assess and monitor these advanced therapy products; technical requirements that are tailored to the therapies; strengthened requirements for risk management and traceability; and incentives for small and medium enterprises (SMEs)." The new regulation was introduced to ensure patients throughout Europe receive fair and uniform access to new generations of biologics treatments, and it will take effect in January 2008. Read the article
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Scientists make stem cell research breakthrough
Posted: 7 June 2007
Researchers have produced the equivalent of embryonic stem cells in mice without taking the controversial step of using eggs or destroying embryos. In their experiments on mice, four independent teams of scientists made ordinary skin cells behave like stem cells. If the same can be done with human cells, the procedure could lead to discovering medical treatments without the ethical and political debates surrounding the use of embryos. Embryonic stem cells can help generate many types of tissue. Experts believe they might be used to create transplant new therapies for a long list of ailments and diseases. Shinya Yamanaka of Kyoto University published his initial discovery that m, ice skin cells could behave like stem cells last year. Now that three independent teams have confirmed the findings, researchers are calling it a major break-through. According to the Wall Street Journal: "All manner of s, tem-cell techniques, including controversial embryo-experiments and the newer reprogramming approaches, could benefit," from the research break-through. Read the article
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Personalized cancer medicine becoming reality
Posted: 1 June 2007
Advances in drug discovery, improved technology and increased understanding of genomic knowledge are making personalized medicine for a cancer patients an increasing reality. Companies are gaining faster regulatory approval because the compounds used in personalized medicine generally have fewer side effects. According to DrugResearcher.com, "The news came in the same week as a study in the journal Nature revealed four new genes that appear to raise significantly a woman's risk of getting breast cancer. Scientists from 15 countries conducted the large scale genetic study of nearly 50,000 women, around half of whom had breast cancer and the other half were controls." More than 30 companies have begun clinical development of cancer drugs this year. Read the article
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California, Ontario to work together on stem cells
Posted: 1 June 2007
Leaders from California and Ontario announced this week they will work together to develop cancer-fighting stem cell therapies. At a conference with California Governor Arnold Schwarzenegger, Ontario Premier Dalton McGuinty pledged that Ontario scientists will work closely with California researchers. According to The Globe and Mail: "Schwarzenegger said California has made a commitment to spend $3-billion on stem cell research…The Ontario Institute for Cancer Research will earmark $30-million for cancer stem cell research in Ontario." Read the article
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FDA to tighten up conflict of interest rules for panels
Posted: 29 March 2007
FDA has announced new draft guidelines to tighten financial conflict of interest rules for members of its advisory panels. All prospective FDA advisory committee members are screened before each meeting to assess potential financial conflict of interest. According to FDA News, "The draft guidelines would replace the current FDA Waiver Criteria issued in 2000 and which the FDA feels is too complex. At the moment it is the only guide they have to help them assess whether the FDA's need for an individual's expertise outweighs the potential for a conflict of interest." The new conflict of interest guidelines would clarify the rules on financial interests. If a potential adviser, after allowing for certain exemptions, has disqualifying financial interests in excess of 50,000 US dollars, then he or she would not qualify to participate, regardless of how valuable their expertise might be. FDA invites public comments for the next 60 days before moving to finalize the guidelines. Read the news article
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FDA releases draft guidance on device modifications
Posted: 29 March 2007
FDA has released a new draft guidance that advises manufacturers of Class III devices subject to premarket approval (PMA) requirements on when to use certain PMA supplements. The new draft guidance states that firms must submit PMA supplements prior to making changes that alter the safety or effectiveness of their devices unless certain exceptions apply. Modifications requiring a supplement include changes to a device's indications, labeling, sterilization procedures, expiration date or packaging. The document, "Draft Guidance for Industry and FDA Staff — Modifications to Devices Subject to Premarket Approval (PMA) — The PMA Supplement Decision-Making Process," replaces the draft titled "Modifications to Devices Subject to Premarket Approval — The PMA Supplement Decision Making Process." Read the news article from FDA
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India's government to watch steep drug price hikes
Posted: 22 March 2007
Drug manufacturers who increase the prices of their drugs in India by more than 10% a year will face regulatory action there. The Drugs Price Control Order (DPCO), administered by India's National Pharmaceutical Pricing Authority (NPPA) , mandates price intervention for nonscheduled drugs if an abnormal price hike occurs. To check arbitrary increases in medicine prices, India's chemicals ministry has asked NPPA to keep track of all drugs whose prices rise by 10% in one year. Currently, non-fixed drug prices in India are allowed to increase by up to 20% a year. Read the article
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FDA requests label change for all sleep disorder drug products
Posted: 22 March 2007
The US Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug , products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep-driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event. Along with the labeling revisions, FDA has requested that each product manufacturer send letters to healthcare providers to notify them about the new warnings. Manufacturers will begin sending these letters to providers starting this week. In addition, FDA has requested that manufacturers of sedative-hypnotic products develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken. Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. Read the article
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Health Canada Considers New Drug Monitoring System
Posted: 15 March 2007
Concerns about the postmarket safety of some drugs have prompted the proposal of a new system of monitoring approved drugs in Canada. Health Canada is considering a new system of licensing prescription drugs that would more closely monitor their safety and effectiveness after approved for sale. A discussion paper posted on the department's website proposes progressive licensing for drugs to follow up on them once they are being taken by large numbers of people. Read about the article
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Australian Regulators Propose New Clinical Process
Posted: 15 March 2007
The Australia New Zealand Therapeutic Products Authority (ANZTPA) is proposing two separate routes for the clinical trial approval process. The new scheme—proposed to help the ANZTPA protect public health, foster clinical research and provide timely access to therapeutic products—is based on the same risk-managed principles the agency uses to monitor approved medicines. Studies that are deemed to be 'high risk' would be required to follow the Clinical Trial Assessment (CTA) route, and all other studies would follow the less stringent Clinical Trial Certification (CTC) pathway. ANZTPA also proposes that clinical trials involving the first administration in humans of a "new" substance(s); a novel active implantable (or organ support) medical device; a hybrid medicine/biological device; gene therapy products; Class 4 human cells or tissues; or xenotransplantation, should follow the CTA route. Sponsors directed onto the CTA path would be required to submit a package detailing preclinical and toxicological data; summary quality control data for the manufacturing to date; data relating to any relevant clinical experience; the proposed guidelines for the use of the product in any subsequent clinical trials; a justification for the use of the product in the trial; and a description of how the safety of the participant is protected within the trial protocol. Read about the article
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Report criticizes FDA drug tracking system
Posted: 8 March 2007
According to the Wall Street Journal, a November 2006 report commissioned by FDA found that the computer systems the agency uses to track prescription drugs after they reach the market are "dysfunctional." Efforts to establish a new system have been delayed by at least four years. The report, which was prepared by the Breckenridge Institute, has not been released publicly. The report states that the system is overwhelmed by the more than 400,000 adverse event reports submitted each year. According to the report, FDA has wasted $25 million on efforts to develop a new system. The report also cites "lack of effective leadership and management" within the information technology office as contributing to the problems. In a draft document responding to the report, FDA officials said it is "riddled with editorial conclusions based on misleading or incorrect facts." Read about the article
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FDA issues draft guidance on public availability of information
Posted: 8 March 2007
FDA has issued "Draft Guidance for Industry Advisory Committee Meetings — Preparation and Public Availability of Information Given to Advisory Committee Members." The document provides guidance to industry sponsors, applicants, and petitioners (referred to collectively as sponsors) who develop, prepare, or submit briefing materials that will be given to advisory committee members as background information before an open FDA advisory committee meeting. T, he, guidance will help sponsors develop, organize, and submit advisory committee briefing materials for public release and should help minimize the time and resources spent in preparing these materials for public availability. The guidance also describes the process FDA intends to follow when we make briefing materials available to the public. In addition, the Appendices provide recommended timelines for preparing and submitting briefing materials to us. An important goal of this guidance is to help ensure that briefing materials are made available to the public as provided under section 10(b) of the Federal Advisory. Read the guidance (pdf)
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Modification of clinical trials regulation spurs new MHRA guidance
Posted: 8 March 2007
An amendment to Regulation 29A of the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended by Statutory Instrument 2006/1928, contains a requirement for the notification of "serious breaches" of GCP or the trial protocol. To address this change, the Medicines and Healthcare products Regulatory Agency in the UK has issued guidance that outlines practical notification arrangements for "serious breaches." It provides advice on what should be classified as a "serious breach" and be reported. Possible actions that MHRA may take in response to serious breach notifications are outlined. More information.
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Counterfeit drugs on the rise
Posted: 8 March 2007
Cut-rate counterfeit drugs are flooding the market via the Internet and mail order, according to the UN's International Narcotics Control Board (INCB). A World Health Organisation study estimates that 25–50% of medicines consumed in developing countries are counterfeit. INCB's 2006 annual report notes that an increasing variety and amount of fake drug products are available. It is estimated that as many as 2,500 people died in Africa in 1995 after being administered counterfeit vaccines. Read the article
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Bill would delay US , launch of 'authorized generics'
Posted: 1 March 2007
A bill has been introduced in the US Congress that would ban the launch of "authorized generics" during the 180-day exclusivity period. If approved, the move could upset the generics market, worth more than $20 billion in the United States. Authorized generics are controversial because they are promoted by the patent holder of the original drug. Since they are not new drugs, but are simply repackaged versions of branded drugs, they can slip through a loophole to compete against genuinely new generics, subverting the 180-day rule. Some branded manufacturers have set up their own in-house divisions to market authorized generics. Read the article
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Canadian provinces to collaborate on cancer drugs
Posted: 1 March 2007
All Canadian provinces except for Quebec have agreed to abandon independent evaluations of new cancer drugs in favor of a collaborative review process. According to Canada's Joint Oncology Drug Review, the move will reduce duplication and help ensure faster, more effective evaluation of cancer drugs. Cancer Care Ontario is an umbrella organization that steers and co-ordinates Ontario's cancer services and prevention efforts. As of 1 March, manufacturers of new cancer medications began only making one submission asking provinces to cover the cost of the drugs. The submission, to an Ontario evaluation committee, would be considered a request to all the participating provinces and territories. Final coverage decisions, however, will remain the responsibility of each jurisdiction. Read the news item
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FDA Issues New Guidance on PEPFAR Product User Fees
Posted: 22 February 2007
The US Food and Drug Administration (FDA) has released, Guidance for Industry: User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR. The guidance outlines the conditions under which user fees will not be assessed or will be waived for some applications for fixed dose combination (FDC) and co-packaged versions of previously approved antiretroviral therapies for the treatment of HIV. Generic drugs submitted under Section 505(j) of the Food, Drug & Cosmetic Act would not be assessed fees; neither would applications submitted under Section 505(b)(2) of the FD&C Act, so long as they do not request approval of a new molecular entity or unapproved indication for use. Any application submitted under 505(b)(1) or 505 (b)(2) that does not require clinical data for approval would be assess a half fee. Three waiver possibilities exist for firms whose applications will be assessed either a full or half fee: small business waiver, public health waiver and barrier-to-innovation waiver. Read the guidance (pdf)
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GPhA Supports The Access to Life-Saving Medicine Act
Posted: 22 February 2007
The Generic Pharmaceutical Association (GPhA) is throwing its support behind bipartisan legislation that will bring safe, effective and affordable biogenerics to consumers. The Access to Life-Saving Medicine Act will create a safe and effective abbreviated Food and Drug Administration (FDA) approval pathway to give consumers timely access to biogeneric products. Approval and introduction of biogenerics would save health care systems and consumers millions of dollars over the traditional biologics products. Read the article
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FDA to Accelerate Enforcement of Unapproved Drugs
Posted: 15 February 2007
FDA has announced plans to step up enforcement of regulations that deal with unapproved and unregulated drugs. According to an FDA spokesperson, "working groups are meeting weekly to review priorities, evaluate options, identify avenues for investigation and address other issues that arise." The FDA spokesperson also said that many people are surprised to learn that many drugs never received FDA approval. For many years federal law did not require that drugs show proof of effectiveness—and did not always require that they be proven safe. Between 1938 and 1962, drugs that were considered identical, related, or similar (IRS) to an approved drug were often marketed without independent approval. Many were marketed based on the manufacturers' belief they were "generally recognized as safe" (GRAS), while others were marketed based on FDA opinions that they were not "new" drugs – all interpretations that were formally revoked in 1968 (21 CFR 310.100). Read the article.
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UK Revie, ws Marketing Authorization Process
Posted: 15 February 2007
UK's process for approval of national marketing authorization applications submitted under Article 10c of the Directive ('simple abridged applications') has been reviewed within the Better Regulation of Medicines Initiative. For national applications submitted under this Article, a checklist has been devised in order to improve the quality of applications and reduce or eliminate the need for requests for further information from applicants. This process is not limited to over-the-counter (OTC) medicines and is applicable to all national marketing authorization (MA) applications under Article 10c.Two mechanisms are to be introduced to facilitate approval.
Where reference licenses have been maintained according to current regulatory requirements:
Applications for the new informed consent marketing authorization that fully comply with current regulations and do not propose changes (other than MA holder, distributor, storage sites, assembler or importer, simple change of flavor or identification markings for solid oral dosage forms), should be assessed within 90 days of receipt. Requests for further information will be unnecessary for compliant applications. More information.
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New Forecasting Tool Could Reduce Drug Development Costs
Posted: 7 February 2007
Researchers from the Children's Hospital Boston Informatics Program (CHIP) have developed a forecasting model that may increase the efficiency of drug R&D and save hundreds of millions of dollars per new drug. The researches also argue that more data sharing by the drug industry—particularly of "negative" data—would greatly improve the accuracy of forecasting and benefit industry and patients alike, allowing more medical discoveries to be brought to the bedside.
The researchers constructed a Bayesian network model to calculate the probability that a given new drug would pass successfully through Phase III trials and receive New Drug Application (NDA) approval. Their approach differs from convention in modeling populations of drugs rather than populations of patients. They used publicly available safety and efficacy data for about 500 successful and failed new drugs, broken down by therapeutic category, then confirmed the validity of their model by testing it with a group of cancer drugs whose fates are already known. Read the article.
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Many Promised Drug Studies Haven't Begun
Posted: 7 February 2007
According to new reports, drug manufacturers have not begun more than two out of every three pending studies that they promised to do after their products were approved by U.S. regulators. FDA has determined that 899, or 71 percent, of 1,259 post-approval studies hadn't been started as of 30 September 2006. The numbers do not include completed studies. To receive FDA approval, drugmakers often agree to perform additional studies of safety after medications come to market. FDA says it is looking at ways to better work with drugmakers to design and complete the studies and to improve its ability to track and monitor the studies. Drugmakers say they are committed to completing the studies. Read the document
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Draft Antimicrobial Susceptibility Testing SOP Released
Posted: 7 February 2007
A draft Standard Operating Procedure (SOP), developed jointly by EMEA/CHMP and the European Committee on Antimicrobial Susceptibility Testing, has been released for consultation. SOP on Harmonisation of European Breakpoints Antimicrobial Susceptibility Testing Set by EMEA/CHMP and EUCAST applies to Product Team Leaders in the human preauthorization unit, (co)rapporteurs and clinical/nonclinical experts involved in assessing microbiological data and setting susceptibility breakpoints for antibacterial agents intended for systemic use. It also applies to relevant EUCAST members. While primarily describing the procedure for new marketing authorization applications, it also applies to: variations of existing MAs that might potentially impact the information on breakpoints in the SPC (e.g., indication extensions, new dosage recommendations) and revisions to susceptibility test breakpoints during the postauthorisation phase. Read the SOP.
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FDA to Expand Access to Experimental Drugs
Posted: 2 February 2007
FDA is expected to expand access to experimental medications for terminally ill patients later this year. Experimental medications are drugs that are in clinical trials or at an early development stage and have not been approved by FDA to be sold on the market. Last month, FDA proposed to expand patients' drug access by making it easier for physicians and other providers such as hospitals to understand when they can obtain unapproved medications. Additionally, in the U.S. Court of Appeals for the District of Columbia, a groundbreaking case is examining whether terminally ill patients have a right of due process to experimental drugs. If successful, the lawsuit would break the long-standing regulation that a drug must undergo three phases of testing before becoming available to the public. Read the article.
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EMEA Issues Revised Checking Process
Posted: 2 February 2007
EMEA has issued The Revised Checking Process of Mock-Ups and Specimens of outer/immediate labeling and package leaflets of human medicinal products in the Centralized Procedure. This document presents the proposed revised mock-up and specimen checking process for human medicinal products and provides further details on its practical implementation. Mock-up and specimen requirements have been substantially reduced, recognizing the responsibilities of the marketing authorization holder, while still acknowledging the importance of printed packaging materials for the correct and safe use of medicines. EMEA will review its experience with the revised checking procedure after 1 year of implementation and consider, in consultation with interested parties, whether any further amendments/process simplification can be introduced. Read the document (pdf)
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DHHS Issues Updated Guidance on Clinical Trials Reporting
Posted: 2 February 2007
Released by the Office for Human Research Protections (OHRP), an updated guideline from DHHS, requires that all "unanticipated problems" in government-sanctioned clinical trials be reported, noting that such events will "warrant consideration of substantive changes in the research protocol or informed consent process/document or other corrective actions in order to protect the safety, welfare, or rights of subjects." OHRP, however, noted that "unanticipated problems" should not be confused with adverse events, the majority of which are not unanticipated. Read the article.
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PDUFA Has Made a Difference at FDA
Posted: 2 February 2007
Since it was passed initially in 1992, the Prescription Drug User Fee Act (PDUFA) has meant shorter approval times for many healthcare products and fast-track approval for some. An amendment PDUFA II in 1997 sought to give manufacturers leeway in promoting prescription drugs for off-label uses, but a legal tussle between FDA and industry left that provision up in the air. Today, manufacturers cannot directly market drugs for off-label use, but discussions of such use are permitted. PDUFA is up for reauthorization this year and there is much speculation about potential modifications to the existing law. Read the guide.
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