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Dec 19, 20232 min read

USFDA MD Guidance: Use of RWE to Support Regulatory Decision-Making forMedical Devices

Recently (14 December 2023) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices...

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...