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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 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...

Nov 1, 20221 min read

USFDA Guidance: Expanded Access to IND Q&A and Assessing User Fees under OMUFA

Earlier Today (1-November-2022), the U.S. Food and Drug Administration issued a revised draft guidance for the industry, “Expanded Access...

Mar 15, 20221 min read

FDA's: OTC Monograph Drug User Fees for Fiscal Year 2022

Yesterday USFDA published the fees for over-the-counter (OTC) monograph drugs for fiscal year (FY) 2022 in a Federal Register Notice...

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...