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 2: Combination Products by Type

Session Chair(s)

Carol H. Danielson, DrPH, MS, RAC

President

Regulatory Advantage, LLC, United States

Single entity combinations
Co-packaged combinations
Cross-labeled combinations
Not combinations under 21 CFR 3.23.2

Companion diagnostics
Fixed dose combinations