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Jul 313 min read

USFDA Guidance: User Fee Programs: GDUFA, BSUFA, OMOR, and MDUFA

On July 31, 2024 the U.S. Food and Drug Administration (FDA) recently published in the Federal Register notice (FRN) the User Fee Rates...

Oct 6, 20221 min read

USFDA Guidance: Four Finalized User Fees and Refunds related Medical Devices Guidelines

USFDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research finalized and released four Medical...

Aug 13, 20212 min read

FY2022 User Fee Table -USFDA

The User Fee programs help the Food and Drug Administration (FDA) to fulfill its mission of protecting public health and accelerating...