Harmonization Efforts by Pharmacopoeias and Regulatory Agencies (PDF)
The authors take a closer look at these ongoing efforts to harmonize compendial standards, with perspective that may be helpful in considering the future direction of pharmacopoeias.
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Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
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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.
