Regulatory Affairs for Combination Products

Attend this virtual training course to learn about FDA's approach to regulation of combination products, the processes to streamline development of single entity, and aligning requirements between drugs and devices.

戻る Agenda

Session 12: Good Manufacturing Practices for Combination Products

Session Chair(s)

Carol H. Danielson, DrPH, MS, RAC

President

Regulatory Advantage, LLC, United States

Streamlined Approach

Drug-based system
Device-based system