FDA's advisory committee process has long been criticized for conflict of interest issues. But now those on the inside are questioning whether change is needed. At the same time, some FDA officials don't believe advisory committees add much to the review process. And given resource constraints, FDA is holding committees less and less often. That may be good news for drug sponsors. The public disclosure of an NDA as part of the committee process leaves sponsors vulnerable to attacks that can undermine the future of a drug. Given the sway advisory committees in the court of public opinion, a re-examination of the system is coming.
By Kate Rawson
Advisory committees are under attack.
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The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.
Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.
Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.
Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.
