John Whyte is starting his tenure as CDER’s Director of Professional Affairs and Stakeholder Engagement by overseeing the Safe Use Initiative.
CDER Outreach Coordinator’s First Task Is Safe Use Initiative
John Whyte joins FDA from Discovery Channel to be director of professional affairs and stakeholder engagement.
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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.
Most, if not all, adcomm support staff in the drug and biologic centers who handled meeting-specific tasks have been laid off, although sponsors still are preparing for the public reviews. Meanwhile, some cut FDA employees are being called back to work for "continuity of operations activities."
Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.
Pink Sheet reporter and editors discuss how the massive layoffs will reshape the FDA and its impact on the drug and biologics industries.