Coronavirus Notebook: US FDA's Paper Push, Industry Execs/US Officials Emphasize Their Collaboration

Dispatches from a world turned upside down include the US FDA expressing confidence in Chinese manufacturers – to make their GDUFA payments; projections of drug shortages for ventilator patients; and the launch of new hydroxychloroquine studies.

Coronavirus map

As the completely abnormal starts to feel routine, the Pink Sheet offers periodic dispatches about how the coronavirus pandemic is changing the operations of sponsors and regulators. Here are some recent stories from the United States.

Pharma executives and other stakeholders had a call with US Food and Drug Administration Commissioner Stephen Hahn twice in five...

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

 

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

 

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

 
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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

 

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.

More from Agency Leadership

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

 

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

 

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

 

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.