FDA Encourages Flexible, Innovative Clinical Trial Design For Regenerative Medicine

FDA's biologics center will encourage flexible clinical trial designs for regenerative medicine by considering trials that incorporate adaptive designs, enrichment strategies or novel endpoints. And, unlike for breakthrough products, a regenerative medicine advanced therapy (RMAT) designation won't require evidence that a drug may offer a substantial improvement over available therapies, the agency reveals in recently released draft guidance detailing the expedited pathways available for regenerative medicine therapies. The guidance, “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions,” was one...