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.

Back to Agenda

Session 3: Determining Regulatory Route for Approval

Session Chair(s)

Carol H. Danielson, DrPH, MS, RAC

President

Regulatory Advantage, LLC, United States

Primary Mode of Action
Request for 0designation
Precedents and examples
Applicants