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Sep 21, 20232 min read

USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants -PDUFA Products

The FDA Center for Drug Evaluation and Research, along with the FDA Center for Biologics Evaluation and Research, issued a revised draft...

May 4, 20231 min read

USFDA Guidance: Assessing User Fees Under the PDUFA of 2022

This Monday (01 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics...

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...