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Drug Development, Not Conflicts, Dominates Gottlieb's Confirmation Hearing

 
• By Derrick Gingery

The most questions were asked about issues such as accelerated approval and clinical trials, not Gottlieb's ties to industry.

Scott Gottlieb's industry ties and potential for a conflict of interest generated wide-spread discussion upon his nomination as FDA commissioner, but other topics took center stage during his Senate confirmation hearing.

A Pink Sheet analysis of the 60 asked questions by members of the Senate Health, Education, Labor and Pensions Committee...

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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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