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Sharan Murugan
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...
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Sharan Murugan
Sep 8, 20221 min read
USFDA Guidance: Clinical Pharmacology Considerations for Pediatric Studies of Drugs & Biologics
Yesterday 07-September-2022, USFDA's Center for Drug Evaluation and Research published a draft guideline "General Clinical Pharmacology...
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