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Home » Final GDUFA I Guidance Clarifies Penalties for Unpaid User Fees
Final GDUFA I Guidance Clarifies Penalties for Unpaid User Fees
Generics makers that do not pay user fees on time will be charged penalties and interest, the FDA said in a final Q&A guidance on GDUFA I, the generics user free agreement that expires on Sept. 30, 2017.