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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.

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More from US FDA

Political Influence And The US FDA: A New Era?

 
• By Michael McCaughan

FDA Commissioner Martin Makary declared during an interview with former Fox News host Megyn Kelly that there “should be nothing political” about the US FDA, but it feels like politics is infecting the agency in unprecedented ways about three weeks into his tenure.

US FDA Retirements Continue Unabated With Drug Inspectorate Leaders, Former Chief Counsel

 
• By Sue Sutter and Derrick Gingery

Alonza Cruse, director of the Office of Human and Animal Drugs Inspectorate, and two other senior inspection officials are departing, along with Mark Raza, chief counsel from 2021 until January.

FDA Leadership Shuffle Continues: Lowell Zeta Returns As OPDP, OGD Leaders Depart

 
• By Sue Sutter and Derrick Gingery

Lowell Zeta, a senior counselor at the FDA from 2020 to 2021, returns as deputy commissioner for strategic initiatives. The agency also names a new acting CIO and acting CVM director, but OGD's Ted Sherwood and OPDP's Catherine Gray retired.

US FDA’s Makary Floats Vague ‘Plausible Mechanism’ Approval Pathway For Rare Diseases

 
• By Sarah Karlin-Smith

Ascertaining the novelty and benefits of Makary’s new drug approval idea – along with what it would take to implement it – requires more clarity on the types of studies he envisions being used to grant and confirm “plausible mechanism’ approvals.

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