martes, 9 de septiembre de 2025

Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment Public Meeting September 24, 2025

https://www.fda.gov/drugs/news-events-human-drugs/prescription-drug-user-fee-act-and-biosimilar-user-fee-amendments-hiring-and-retention-assessment?utm_medium=email&utm_source=govdelivery Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment Public Meeting Date: Wed, Sept. 24, 2025; 9 a.m. - noon ET The FDA is holding a hybrid public meeting titled "Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment." The meeting includes an opportunity for public comment. This public meeting is being held to meet performance commitments included in the Prescription Drug User Fee Act (PDUFA VII) and the Biosimilar User Fee Amendments (BsUFA III). During the public meeting, FDA will share high-level findings from a third-party assessment of FDA’s hiring and retention of staff for the human drug review program conducted by an independent contractor, Eastern Research Group, Inc. (ERG). https://www.eventbrite.com/e/public-meeting-on-pdufa-vii-bsufa-iii-hiring-and-retention-assessment-tickets-1510576247219?aff=oddtdtcreator&utm_medium=email&utm_source=govdelivery

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