Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches

Innovative manufacturing technologies have the potential to improve the manufacture of pharmaceuticals and bring benefits to patients.  Such benefits include increased manufacturing agility, reduced susceptibility to shortages, and improved measurement and control of product quality. The widespread adoption of innovative pharmaceutical manufacturing technologies has not yet been realized, as stakeholders cite potential barriers to technology adoption.  

On June 8, 2023, the Duke-Margolis Center for Health Policy, under a cooperative agreement with the U.S. Food and Drug Administration (FDA), will convene a public workshop focused on regulatory strategies to support the utilization of innovative manufacturing technologies for drugs and biological products. The workshop will be hosted as a hybrid (in-person and virtual) meeting. A series of presentations and panel discussions by FDA and participants will cover: 

• Best practices and lessons learned from the CDER Emerging Technology Team and CBER Advanced Technology Team programs from both industry and regulatory perspectives
• Case studies from sponsors of previous submissions using innovative manufacturing approaches
• Barriers to the adoption of innovative manufacturing technologies 
• Regulatory strategies for the adoption of advanced manufacturing technologies
• Science- and risk-based approaches for developing and assessing innovative technologies across platform products and sites to streamline adoption
• Initiation and implementation of the Advanced Manufacturing Technologies Designation Program

This workshop is intended to solicit industry and public feedback to fulfill the commitments described in the FDA User Fee Reauthorization Act of 2022, and in accordance with commitments described in the Prescription Drug User Fee Act (PDUFA) VII commitment letter "PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 through 2027,” related to advancing utilization and implementation of innovative manufacturing, as well as section 506L(e)(1) of the Federal Food, Drug, and Cosmetic Act, as amended by section 3213 of the Food and Drug Omnibus Reform Act of 2022 (FDORA) regarding the Advanced Manufacturing Technologies Designation Program.