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Feb 171 min read

USFDA Guidance: Q&A-Charging for Investigational Drugs Under an IND - What You Need to Know

Earlier this week (14 February, 2024) the the U.S. Food and Drug Administration (FDA) released guidance "Charging for Investigational...

Sep 11, 20232 min read

USFDA Guidance: IRB Review of Individual Patient Expanded Access Submissions & Peptide Drug Products

Earlier today (11 September 2023), The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Center for...

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Earlier Today (1-November-2022), the U.S. Food and Drug Administration issued a revised draft guidance for the industry, “Expanded Access...