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FDA Neuroscience Director Dunn's Appearance At Tanezumab AdComm Confirms Neurology Office Is Intact

 
• By Ramsey Baghdadi

Dunn’s participation at the panel meeting ended speculation that he left the US FDA.  

Dunn Will By Key A Figure In Alzheimer's Drug Review

“Good morning. This is Dr. Billy Dunn. I’m the director of the Office of Neuroscience at the FDA.” And with that, any speculation about Dunn and his position at FDA was put temporarily to rest.

Those were the only words said by Dunn during the joint advisory committee review of Pfizer Inc.’s tanezumab. He...

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BIO CEO On Industry And US FDA, Trump’s Vaccine Views And MFN Counter Proposals

 
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John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.

New CDER Deputy Director Michael Davis Brings Psychedelic Drug Development Experience

 
• By Sue Sutter

Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.

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.

More from Agency Leadership

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.