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Memo To US FDA: ‘Too Fast!’ Plus ‘Too Slow!’ Does Not Mean ‘Just Right!’

 
• By Michael McCaughan

There is an old adage that FDA only has two speeds: too fast and too slow. Recent pushback on neurology reviews and Covid vaccines show that paradox – but also the flaw of treating contradictory criticism as a sign that everything is actually fine.

US FDA has much more sophisticated decisions to make. • Source: Alamy

US Food & Drug Administration Center for Drug Evaluation & Research Director Patrizia Cavazzoni’s first appearance as a Congressional witness in her new role as the top drug regulator at FDA must have felt disconcerting.

She appeared before the House Energy & Commerce/Health Subcommittee on 29 July after weeks of headlines about FDA’s decision to grant Accelerated Approval to Biogen, Inc./Eisai Co., Ltd.’s...

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US FDA Makary’s Pharma CEO Tour Goes Against Transparency Rhetoric

 
• By Sarah Karlin-Smith

FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

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.

US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots

 
• By Sarah Karlin-Smith

The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

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