Regulatory Affairs for Combination Products

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.

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Session 10: Post-Approval Changes

Session Chair(s)

Carol H. Danielson, DrPH, MS, RAC

President

Regulatory Advantage, LLC, United States

Device and drug changes made to products approved via PMA
Device and drug changes made to products approved via NDA