Generic Facility Fee Unlikely To Be Charged Until A Few Months After GDUFA Implementation
This article was originally published in The Pink Sheet Daily
FDA will need a bit of time to develop a comprehensive database of all the facilities that produce active pharmaceutical ingredients and finished dosage forms for the U.S. market as part of the proposed generic drug user fee program.
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Since applications comprise most of the workload, they will be the focus in the next generic drug user fee cycle.
Fewer fee-paying facilities than estimated self-identified with the agency as part of the launch of the generic drug user fee program, which helped increase the fees about 17% more than anticipated for domestic finished dosage form facilities.
API, finished dosage form and other facilities in the generic drug supply chain must submit information to FDA by Dec. 3. As of Nov. 18, about one-third had complied, potentially affecting user fee amounts.