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Alison Falb

Regulatory Counsel, OTBB, OND, CDER

Alison Falb is a Regulatory Counsel in CDER’s Office of Therapeutic Biologics and Biosimilars, which oversees the development and implementation of regulatory policy related to biosimilar, interchangeable, or other therapeutic biologic products. Prior to joining the Office of Therapeutic Biologics and Biosimilars, Ms. Falb was a Senior Advisor at the Center for Medicare and Medicaid Innovation (CMMI) at the Centers for Medicare & Medicaid Services where she led policy development for specialty care and episode-based payment models under the MACRA statute and designed and implemented alternative payment models. She earned her J.D., cum laude, from Fordham University School of Law and her B.A. in psychology from Brown University.

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