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Gottlieb's Parting Words For US FDA: 'Be Willing To Push' For Major Policy Changes

 
• By Derrick Gingery

Outgoing Commissioner tells staff, “No phrase bothered me more than when I heard people say to me they didn’t want to do something important because they wanted to ‘preserve their political capital.’” FDA should not to worry about spending political capital, Gottlieb argued, because it is replenished upon accomplishing important things.

Gottlieb speaking
Outgoing FDA Commissioner Scott Gottlieb addresses employees during the final all-hands meeting of his tenure. • Source: HHS photo

Outgoing Commissioner Scott Gottlieb exited the US FDA proud and unapologetic about the sometimes contentious issues he took on during his tenure, telling staff that the commissioner must be willing to challenge "powerful interests and policy makers."

In a farewell speech to employees on April 4, Gottlieb said an agency head must seek support, but also "assert...

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Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
• By Michael McCaughan

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.

Branch Chief Vijay Kumar Named Acting Head Of US FDA’s Cell, Gene Therapy Office

 
• By Derrick Gingery

Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

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.

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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.