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AAOS Now, August 2021

FDA Ends Enforcement Discretion on Biologics and Regenerative Products

S. Raymond Golish, MD, PhD, MBA, FAAOS; Ryan Pezold, MA; David S. Jevsevar, MD, MBA, FAAOS

The FDA has formally ended the “enforcement discretion” of its comprehensive policy framework on biologics and regenerative medicine products.

AAOS Now, August 2021

FDA Ends Enforcement Discretion on Biologics and Regenerative Products