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‘Bruised’ But Not Broken: Ex-Commissioners See FDA Intact Amid Transition

 
• By Laura Helbling

Three former commissioners believe FDA has come through the Trump Administration relatively unscathed when compared to the reputational damage suffered by other government agencies. Will the Biden team agree?

When it comes to the FDA, How much will the Biden administration squeeze the produce? • Source: Sutterstock

Three former commissioners of the US Food & Drug Administration agree that the agency has made it through the tumultuous Trump years without fundamental damage.

“Out of all the federal agencies, the FDA and the [National Institutes of Health] fared the best in this last...

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US FDA’s Top Cell and Gene Therapy Regulators Forced Out

 
• By Sarah Karlin-Smith

Office of Therapeutic Products Director Nicole Verdun and her deputy Rachael Anatol were escorted out of FDA headquarters on June 18. Disagreements over CAR-T regulation and Capricor’s DMD treatment may be to blame.

First Among Equals: US FDA CBER Director Prasad Gains Agency-Wide Authority

 
• By Bridget Silverman

As Chief Medical and Scientific Officer, Vinay Prasad will advise the FDA Commissioner on cross-cutting issues, provide strategic leadership and be a public face of the agency.

BIO Notebook: Policy Problems, ACIP’s Future, BI Is Popular, Makary On FDA-Industry Ties

 
• By Sarah Karlin-Smith and Mandy Jackson

Highlights from Day Two of the BIO International Convention include BIO officials raising concerns about Trump Administration policies, the future of ACIP, an interview with BI's head of global business development, and FDA Commissioner Martin Makary's view of the FDA-industry relationship.