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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...

Apr 4, 20232 min read

UK MHRA: MHRA Fees 2023 & Guidance on How to Draft a Direct Health Care Professional Communication

Statutory guidance on MHRA fees A new statutory fee for MHRA services was introduced on April 1, 2023, by the Medicines and Healthcare...

Oct 6, 20222 min read

USFDA Guidance : GDUFA III User Fees & 4 Generic Drug related Guidances

USFDA finalized and released four Guidelines yesterday (05 October 2022), in accordance with the time frames set forth in the Generic...

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...

May 18, 20221 min read

Generic Drug User Fee Guidance - Assessing User Fees - USFDA

The Generic Drug User Fee Amendments of 2012 (GDUFA I) added sections authorizing FDA to assess and collect user fees for a five-year...