Office of Pharmaceutical Quality Experiential Learning Site Visit Program; Program Announcement

https://www.federalregister.gov/documents/2024/08/08/2024-17640/office-of-pharmaceutical-quality-experiential-learning-site-visit-program-program-announcement The U.S. Food and Drug Administration is accepting drug companies’ proposals to participate in the fiscal year 2025 site visitation program. In this program, FDA staff observe operations of commercial manufacturing, pilot plants, and testing operations to gain a better understanding of the pharmaceutical industry and its operations, as well as the challenges impacting a drug’s developmental program and commercial life cycle. FDA encourages companies engaging in the development and manufacturing of both active pharmaceutical ingredients (small and large molecules) and drug products to participate. The agency will select facilities based on priorities for FDA staff training, a facility’s current compliance status with FDA, and other considerations. This program does not supplement or replace a regulatory inspection. Starting October 1, companies interested in offering a site visit or learning more about this program should submit a proposal to CDEROPQSiteVisits@fda.hhs.gov.