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US FDA Publishes, Then Withdraws, PDUFA Rates Because Process ‘May Not Be Well Understood’

 
• By Derrick Gingery

User fees for FY 2021 were set to increase nearly 11%, but could have gone even higher; a new notice will be issued but timing is unclear.

Cash drawer with currency
FDA officials announced the new prescription drug user fees, but then withdrew the notice. • Source: Alamy

US Food and Drug Administration officials decided to pull the announcement of fiscal year 2022 prescription drug user fees apparently due to a misunderstanding of the calculations.

The unusual move came as the agency had decided to raise application fees nearly 11% and the program fee more than 12%. Sponsors were going to be charged nearly $3.2m...

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US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

 
• By Derrick Gingery, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

 
• By Cathy Kelly

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

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