Advisory committee reform efforts in the US Food and Drug Administration’s Center for Drug Evaluation and Research include product-specific adjustments to the group offering advice.
Expect More Temporary Members Voting In US FDA Advisory Committees
Reform efforts in CDER include ensuring expertise is specific to the issues being discussed, which may mean more temporary voting members on advisory committees.

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The agency’s compliance directors also discussed expectations for greater inspection and review efficiencies as part of the 1 October reorganization during a recent FDLI conference.
The compounding industry ties for Martin Makary, President-elect Trump’s candidate to lead the FDA, could mean less compounding enforcement, experts said, but government officials said their enforcement focus will remain nonpartisan.
The loss of institutional knowledge about OPDP’s prior comments on promotional materials can result in an enforcement letter for the new owner of a company or product, experts say.
Written contracts should be detailed, require compliance with FTC and FDA requirements, and guard against activities that may damage a company’s reputation, experts said.
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Pink Sheet reporter and editors discuss how staff may not be the only thing the FDA could lose with the latest layoffs announced by the Health and Human Services Department.
The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.