Article FDA Thank You How to handle a warning letter: FDA’s new meeting type benefits generic drug companies
Agency IQ
SEPTEMBER 6, 2023
This impact was apparently enough for the FDA and generic pharmaceuticals industry to include a new meeting type in the most recent iteration of the Generic Drug User Fee program (GDUFA), called a “Post-Warning Letter Meeting.” In FY2025, that will increase to a goal of 70%, and in FY2026-2027, it will increase to 80%.
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