Latest from Sarah Karlin-Smith
Martin Makary’s photo-op and videos promoting the groundbreaking of a new Novartis US-based manufacturing facility create an appearance of favoritism, President George W. Bush’s former chief ethics lawyer told the Pink Sheet.
As differences emerged between FDA staff and senior political leaders over its COVID-19 safety review, CBER Director Vinay Prasad added an old colleague and critic of US COVID-19 policy to the center.
At an expert panel overwhelmingly composed of people favoring expanded testosterone use and loosened safety warnings, career FDA staff suggested new clinical trials would be required to approve some of the changes.
Experts said the impact of the planned approval standard changes are difficult to assess given the potential for flexibility outlined in the JAMA article, as the FDA again eschews guidance and public comment in making new policy.
Pink Sheet reporter and editors discuss the likely impacts of Center for Drug Evaluation and Research Director Richard Pazdur’s retirement from the FDA and Tracy Beth Høeg becoming the center’s acting director.
At a CDC vaccine advisory committee criticized for “promoting an anti-vaccine agenda,” the new CDER director championed the committee’s plans and suggested the FDA would make more frequent vaccine label updates due to revised safety frameworks.
