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15 December 2011
Following a successful pilot program, FDA and EMA will begin sharing the work of inspecting pharmaceutical manufacturing facilities in their respective regions.
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15 December 2011
New legislation introduced in the US Senate this week would compel manufacturers of certain medical implants to more closely monitor their products after they have been approved and are on the market.
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8 December 2011
In an unprecedented move, US Health and Human Services Secretary Kathleen Sebelius overruled a decision by FDA to allow over-the-counter sales of the “morning-after” contraceptive pill to women younger than 17.
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8 December 2011
China’s State Council this week approved a five-year plan to bolster the country’s drug safety standards.
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1 December 2011
The Court of Justice of the European Union (CJEU), the EU’s highest court, issued a ruling last week that extended patent protection for drugs and vaccines that are used in to treat multiple diseases.
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1 December 2011
Recent approvals by FDA of companion diagnostics for use in oncology bode well for the future of coordinated drug/diagnostic development, however, questions remain.
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17 November 2011
A plan in the works from Sen. Kay Hagan of North Carolina, working closely with BIO, would expand the FDA accelerated approval program for drugs for unmet needs.
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17 November 2011
China this week took significant steps against the country’s counterfeit drug producers, establishing a new national anti-counterfeiting office and seizing the equivalent of $315 million (US) worth of fake drugs and packaging.
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10 November 2011
EMA is under investigation by the European Anti-Fraud Office regarding alleged conflicts of interest in the wake of a scandal over a French diabetes drug removed from the market in 2009.
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10 November 2011
The Institute of Medicine this week released a new report recommending a brand new agency be created to regulate health information technology, and that FDA not be tasked with Health IT oversight.
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3 November 2011
President Obama issued an executive order this week directing FDA to take specific actions to prevent and reduce future drug shortages.
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3 November 2011
MHRA has launched a formal public consultation on the consolidation of UK medicines legislation.
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27 October 2011
As FDA gets closer to making its final recommendations on changes to PDUFA before the US Congress considers its re-authorization, one revision being proposed is increased communication between the agency and product sponsors.
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27 October 2011
As the US Congressional bipartisan “super committee” charged with identifying areas for cutting the federal budget nears its deadline, FTC released a report showing that a ban on pay-for-delay settlements would save $2.67 billion over 10 years.
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20 October 2011
The European Court of Justice this week issued a ruling prohibiting patents for stem cell work involving the destruction of human embryos.
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20 October 2011
FDA has issued a draft guidance proposing lowering the risk classification for external pacemaker pulse generators from Class III to Class II.
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13 October 2011
Under proposed rules released this week, the European Commission (EC) will set strict limits on information drugmakers are allowed to provide directly to patients about prescription medicines.
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13 October 2011
FDA and CMS have launched a pilot parallel medical device review program to increase efficiency and help facilitate the development of innovative new devices.
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6 October 2011
FDA Commissioner Margaret Hamburg unveiled the agency’s blueprint for fostering biomedical innovation to help speed medical advances to patients.
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6 October 2011
EMA this week published a concept paper on its proposed revisions to the agency’s guideline on biosimilars and is seeking public comment.
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29 September 2011
A coalition of 16 European academic and industry groups is calling for major changes to the EU’s Clinical Trials Directive, saying it hinders medical research in the Community.
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29 September 2011
FDA has released a new guidance, Marketed Unapproved Drugs—Compliance Policy Guide, that outlines the agency’s risk-based enforcement priorities for drugs marketed without proper regulatory approval.
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22 September 2011
A new proposal from President Obama would reduce the market exclusivity period for brand-name biologic drugs to seven years, from the 12-year period passed as part of last year’s US healthcare reform bill.
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22 September 2011
Five EU Member States and the European Molecular Biology Laboratory have signed a memorandum of understanding to create an infrastructure to manage and safeguard biological information.
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15 September 2011
In testimony before a Senate committee this week, a top FDA official made the agency’s case for increased powers to police drugs entering the US from abroad.
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15 September 2011
According to a new study, almost 60% of clinical trial protocols for new drugs are amended during the trial, but one-third of those changes could have been avoided.
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8 September 2011
FDA has reached a deal with pharmaceutical industry representatives that will give the agency an additional two months to review new drugs and raise user fees by 6%.
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8 September 2011
New drugs applying for approval in Europe should be tested against the best available comparable medicine, not against a placebo, as is the current EMA requirement, says a new report.
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1 September 2011
FTC issued its long-awaited final report on “authorized generic” drugs this week, concluding that consumers benefit from these drugs, despite the objections of many generic drugmakers.
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1 September 2011
India’s health ministry has proposed a new rule that would require drugmakers to compensate victims in cases where death or injury was caused by a clinical trial.
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25 August 2011
Last week, FDA unveiled its plan for advancing regulatory science, identifying eight priority areas on which the agency will focus.
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25 August 2011
A recent study found that most pharmaceutical advertisements in biomedical journals fail to comply with FDA guidelines.
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18 August 2011
A deal to collect user fees from generic drugmakers that would finance expanded FDA inspections of drug manufacturing facilities around the world is likely to pass Congress, according to reports.
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18 August 2011
This week, as Facebook opened some pharmaceutical industry pages to allow public commenting, drugmakers have been forced to consider the potential consequences of comments or shut down some Facebook pages.
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11 August 2011
Many venture capitalists have reacted strongly to FDA Commissioner Hamburg’s recent op-ed piece in The Wall Street Journal contending that the agency’s cautious approach helps spur economic growth by increasing consumer confidence.
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11 August 2011
FDA officials provided insight into agency thinking on biosimilars approval standards in a New England Journal of Medicine article published last week.
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4 August 2011
Late last week, the Institute of Medicine released a report criticizing FDA’s 510(k) clearance process for medical devices and called for the development of a completely new framework.
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4 August 2011
A pair of pilot programs fostering increased cooperation among health regulators in the US, EU and Australia have been declared successes, paving the way for further international collaboration.
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28 July 2011
FDA released draft guidance this week clarifying what types of changes to a previously-cleared medical device require a new premarket submission.
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28 July 2011
The EU ban on drugmakers communicating directly with patients is set to be reviewed by the European Commission as it plans to draft new rules.
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21 July 2011
The growth of health-related mobile applications spurred FDA this week to release its first guidelines for regulating them.
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21 July 2011
An eight-month government panel investigation into Australia’s TGA calls for the agency to publish results of all its safety investigations, and improve its process for gathering adverse event reports.
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14 July 2011
FDA has reorganized its top management structure and hired former Dartmouth Medical School Dean Stephen Spielberg as commissioner for medical products and tobacco, a new position.
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14 July 2011
Thus far in 2011, FDA has approved 20 new drugs, just one less than the 21 it approved for all of 2010.
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7 July 2011
EMA has provided drugmakers with the specific electronic formats that will be required for information on all drugs authorized or registered in the EU beginning next year.
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7 July 2011
FDA has issued a draft guidance document agency officials hope will clear up confusion over when supplement manufacturers need to notify FDA about new ingredients.