FDA Seeks Ideas to Speed Up Cheaper Generic Drugs
Published Date: 5/19/2025
Notice
Summary
The FDA is gearing up to renew the Generic Drug User Fee program for 2028-2032 and wants your thoughts! This affects drug makers who pay fees to help speed up generic drug reviews. They’re hosting a public meeting and asking for comments before making any changes, with new rules needed by September 2027 to keep things rolling smoothly.
Analyzed Economic Effects
1 provisions identified: 0 benefits, 1 costs, 0 mixed.
GDUFA reauthorization by Sept 2027
If you make generic drugs and pay FDA user fees, the FDA is preparing to reauthorize the Generic Drug User Fee program for fiscal years 2028 through 2032. To keep collecting those fees, new legislation must be enacted by the end of September 2027.
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