Recordings Available - SBIA | Quality and Regulatory Predictability: Shaping USP Standards

By hosting this workshop, the Association for Accessible Medicines (AAM), FDA, and United States Pharmacopeia (USP) aimed to increase stakeholder awareness of, and participation in, the USP standards development process, ultimately contributing to product quality and regulatory predictability throughout the drug development, approval, and product lifecycle. Public quality standards are universally recognized as essential tools that support the design, manufacture, testing, and regulation of drug substances and products. USP standards play a critical role in helping ensure the quality and safety of medicines marketed in the United States and worldwide. This discussion showed how USP public standards strengthen quality, streamline development, support regulatory compliance, and overall, increase regulatory predictability for drugs. Attendees gained insights into the USP standards development process and learned how they can sponsor or participate—via public comment—in the development of future standards. Quality and Regulatory Predictability: Shaping USP Standards December 11, 2025 https://www.fda.gov/drugs/news-events-human-drugs/quality-and-regulatory-predictability-shaping-usp-standards-12112025?utm_medium=email&utm_source=govdelivery