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Potential For Califf’s Second US FDA Commissioner Term Surprises, Excites Stakeholders

 
• By Derrick Gingery

Many supporters believe Robert Califf checks all the boxes, but if nominated he would also face many familiar confirmation challenges.

Food and Drug Administration Commissioner nominee Doctor Robert Califf testifies at his nomination hearing at the Senate Health, Education, Labor and Pensions Committee on Capitol Hill in Washington, November 17, 2015. REUTERS/Gary Cameron
If nominated and confirmed, former FDA commissioner Robert Califf would become only the second person to serve two separate terms in the office. • Source: Reuters/Gary Cameron

Stakeholders seem excited that Robert Califf could be tapped again to head the US Food and Drug Administration, but reaching the commissioner’s office a second time may be tougher, with many of the same issues raised during his first confirmation still lingering.

Califf is a top target for the nomination, the Washington Post first reported. The selection process is not complete;...

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More from US FDA

US FDA Acting Drug Center Chief Corrigan-Curay Retiring, Senior Staff Remake Continues

 
• By Derrick Gingery

The news coincides with rumors that Commissioner Martin Makary soon will name a new Center for Drug Evaluation and Research director.

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.

More from Agency Leadership

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

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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.