A Brief History of Pharmacopoeias: A Global Perspective (PDF)
This article examines the history and evolution of the pharmacopoeias and the particular challenges that must be overcome to achieve harmonization among the pharmacopoeias.
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Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Article
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
