FDA Faces Jan. 15 Deadline for Sending User Fee Commitments to Congress

December 30, 2021

After a series of public meetings throughout the year in preparation for reauthorization by Congress of the FDA’s user fee programs for prescription drugs, generics and biosimilars for fiscal years 2023 to 2027, the agency must now send its commitment letters to lawmakers by Jan. 15.

The FDA released a draft commitment letter in late August for the next reauthorization of the Prescription Drug User Fee Act (PDUFA) — PDUFA VII — for public comment. A month later, the agency released its commitment letter for reauthorization of the Biosimilar User Fee Act (BsUFA). If authorized, BsUFA III will pick up where BsUFA II leaves off on Sept. 30, the end of the current fiscal year.

In late October, the FDA released its draft commitment letter for the reauthorization of the Generic Drug User Fee Act (GDUFA) III. The current user fee program, GDUFA II, is also authorized through the end of fiscal 2022.

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