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

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

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.