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Today (11 August 2023) the United States Food & Drug Administration released a draft guidance “Formal Meetings Between the FDA and...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