US Pharmacopeia 53d ago

In December 2025, the U.S. FDA Small Business and Industry Assistance (SBIA), USP, and the Association for Accessible Medicines (AAM) came together to help industry viewers understand how the three organizations collaborate on USP's public quality standards development, and how industry can benefit from engaging with USP early in their product development lifecycle. Speakers offered an overview of FDA’s role in and use of USP standards; the regulatory value of USP monographs; how industry and manufacturers contribute to standards development; the USP revision process; and ways to participate in monograph development. Timestamps: 0:00:00 - intro 0:00:10 - FDA’s Participation in USP-NF Revision Process – Challenges and Solutions - Pallavi Nithyanandan, Director, Compendial Operations and Standards Staff, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA 0:18:08 - Strengthening Your Compendial Strategy - Matthew Vankoski, Director, Donations, USP 0:49:56 - Industry Engagement in USP’s Standards-Setting Process - Scott Kuzner, Senior Director, Science and Regulatory Affairs, Association for Accessible Medicines 1:13:54 - Q&A with panelists, also featuring Kristie Laurvick, Senior Regulatory Engagement Manager, U.S. Government and Regulatory Affairs, USP