Pharmaceutical Technology April 2025

Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance

April 02, 2025

Ask the Expert

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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.