Podcast: Non-binding Guidance: Examining FDA’s Enforcement Authority Over Stem Cell Clinics and Compounders
Therapies that use autologous or allogeneic stem cells are examples of early personalized therapies. Removing cells from a patient and reintroducing them to the same or a matched patient, for example, as done in bone marrow...more
On November 16, in the context of announcing a comprehensive regenerative medicine policy framework, FDA released a draft guidance document that describes the expedited programs available for the development and review of...more
Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers....more