The End of the FDA Enforcement Discretion Period and its Implications

The end of the FDA Enforcement Discretion Period for certain human cell, tissue, and tissue-based products (HCT/Ps), including regenerative medicine therapies, marks a new chapter in the regulation of stem cell clinics in the United States.

The objective of this webinar is to provide public information that a) summarizes the three years of the FDA Enforcement Discretion Period and reviews its impact on clinics and the market, and b) fosters a discussion among attending and impacted stakeholders on initiatives and strategies to be pursued post Enforcement Discretion Period.