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FDA Seeks OMB Review for Generic Drug User Fee Program Information Collection
May 05, 2025
WASHINGTON, May 5 (TNSFRinfo) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has submitted a proposed information collection to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

This collection supports the implementation of the Generic Drug User Fee Program (GDUFA), which was recently reauthorized on September 30, 2022.

The information collection encompasses the submissi . . .

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