• Regulatory NewsRegulatory News

    FDA Approving Most New Drugs and Biologics During Their First Review, Report Finds

    The US Food and Drug Administration's (FDA) is now approving more new drugs and biologics during their first review cycles than at any time since at least 2008, a new FDA-commissioned report shows. Background The report , conducted by the Eastern Research Group (ERG) on behalf of FDA, is focused on the fifth iteration of the Prescription Drug User Fee Act (PDUFA) , which was passed in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) . P...
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    Japan Launches NIH Analogue

    Today marks the launch of Japan’s new Agency for Medical Research and Development (AMED), which will take on the role of leading research and development in the country through partnerships between universities and industry. The agency’s launch is part of a larger restructuring of Japan’s publicly funded research and development sector. Background AMED was created following the passage of two acts in 2014, The Act on Promotion of Healthcare Policy and the Act on t...
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    FDA Wants Public Input on How to Improve Drug Safety

    If you have an idea for what the US Food and Drug Administration's (FDA) pharmaceutical regulators should be working on, now is the time to speak up. In a Federal Register announcement on 19 March 2015, FDA said it "hopes to foster collaborations with external partners and stakeholders" to help address a long list of regulatory "needs and priorities" identified by its Center for Drug Evaluation and Research (CDER), which is in charge of regulating drug products. The...
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    New Bill Would Reduce FDA Burden on Research-Use Devices

    A new bill introduced in the House of Representatives by a prominent Republican legislator would make it easier for companies to distribute investigational medical devices explicitly labeled as being "for research use only (RUO)." The Medical Testing Availability Act of 2015 , sponsored by Rep. Michael Burgess (R-TX), the vice chairman of the Energy and Commerce Committee's Subcommittee on Health, is similar to an identically titled bill introduced by Burgess in 2013 ....
  • Feature ArticlesFeature Articles

    Fruit Flies––Powerful Foot Soldiers in Genetic Research

    “ Time flies like an arrow; fruit flies like a banana.”––Comedian Groucho Marx Most everyone knows fruit flies gravitate toward bananas and other overripe fruit, and almost magically appear in kitchens around the world. Less well known is the fact this insect species has been used for more than 100 years to study genetics and developmental biology. Perhaps the most remarkable discoveries in these fields have come from research with this persistent pest. Fruit flie...
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    Canada Launches Ebola Vaccine Trial

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. The Canadian Institutes of Health Research (CIHR) and the Public Health Agency of Canada (PHAC) have provided funding for a Phase I clinical trial using Canada’s Ebola vaccine (VSV-EBOV), Canada's Minister of Health, Rona Ambrose, announced last week.  The Canadian Im...
  • FDA Guidance Establishes When an IND May Not be Required to Conduct Human Studies

    The US Food and Drug Administration (FDA) has released a new final guidance document intended to assist sponsors in determining whether a research study involving human subjects may be conducted without first filing an investigational new drug (IND) application with US regulators. Background: The FMT Precedent In recent months, FDA has proven to be somewhat amicable to the idea of extending enforcement discretion-that is, expressing that it won't punish an entity-when h...
  • FDA Plans Multi-Year Investigation Into Rare Side-Effect of Heparin

    The US Food and Drug Administration (FDA) has announced that it will give researchers a quarter of a million dollars to help identify the source of a major safety risk now affecting heparin products. Heparin, a mixture of non-standard-length polysaccharides, acts as an anticoagulant under normal circumstances. However, a notable side effect known as heparin-induced thrombocytopenia (HIT) results in a decrease of platelets in the blood resulting in the release of abnormal...
  • Orphan Drug Manufacturers Would be Exempt from 'Obamacare' Fees Under New Bill

    A new piece of legislation introduced this week by Rep. Jim Gerlach (R-PA) would clarify that developers of orphan pharmaceutical products are exempted from an annual fee otherwise levied on manufacturers to help fund the government's expansion of national healthcare. Background Orphan drug products have long been exempted from a range of fees otherwise levied on other manufacturers. As defined under the Orphan Drug Act of 1983, orphan drugs are those intended to trea...
  • Medical Device Industry Comes Together to Slam Proposed Regulation on Clinical Trials

    The medical device industry is none too pleased with a proposed regulation released in February 2013 that would require all companies to make sure their clinical trials, no matter where in the world those trials are conducted, to adhere to US clinical trials regulations. Background The US Food and Drug Administration's (FDA) draft regulation, Human Subject Protection: Acceptance of Data From Clinical Studies for Medical Devices , would notably require sponsors to o...
  • US Would See Clinical Trials Reporting Transparency Under New Legislation

    Massachusetts U.S. Rep. Ed Markey has announced the reintroduction of legislation that he says is intended to open up clinical trial data, introducing a measure of transparency and bringing the US closer toward reforms now underway in the EU. Background The bill, known as the Trial and Experimental Studies Transparency (TEST) Act , was first introduced in August 2012 by Markey and Rep. Elijah Cummings, a fellow member of the House Energy and Commerce Committee on which...
  • PCORI Giving $68 Million to Build a National Comparative Effectiveness Research Network

    The US' Patient-Centered Outcomes Research Institute (PCORI), a budding comparative effectiveness research (CER) organization formed under the Patient Protection and Affordable Care Act (PPACA) of 2010, has announced its plans to spend as much as $68 million to develop a new clinical research network that it says will bolster the US' capacity to compare treatments. Background PCORI's 2010 founding under the PPACA -better known as "Obamacare" by some-was rife with con...