FDA: The Antidote to Anecdotal Safety Challenges
This article was originally published in RPM Report
Executive SummaryThe Food & Drug Administration's role as the expert arbiter of drug safety issues is traditionally viewed as a threat to commercial products. But the agency also serves as an important protector of companies and products from unverified allegations of safety problems with marketed products or products in development. An important regional biotech trade group, BayBio, focuses on the role of FDA as impartial judge of the importance of clinical reports in a recent filing with the Supreme Court.
You may also be interested in...
FDA is joining the government’s bioresponse and defense efforts to develop small, mobile, on-demand manufacturing systems as next-tech solutions to dwindling domestic supply sources for essential drugs.
How should FDA make sure new safety information gets widely disseminated – especially against a history of many communications that have not shown the sustained ability to reach the most active prescribers? The agency got an earful of suggestions from the most recent safety review of the asthma/allergy drug montelukast.
The use of patent “march-in” rights as a tool to control the price of drugs developed with US federal funding support remains substantially less popular with the government-funded research community than with politicians.