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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...

Aug 10, 20232 min read

USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products

Today (11 August 2023) the United States Food & Drug Administration released a draft guidance “Formal Meetings Between the FDA and...

Aug 1, 20232 min read

USFDA Guidance: Assessing User Fees -BsUFA III: Biosimilar User Fee Amendments of 2022

Today (31 July 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug...

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...