FDA Unveils Regenerative Medicines Framework, Publishes Four Guidances

FDA has introduced a new risk-based framework, accompanied by two final guidances and two new draft guidances, for regulating regenerative medicines, the agency announced Thursday (Nov. 16). The framework, FDA Commissioner Scott Gottlieb said in the announcement, proposes "novel and modern approaches to regulation," including a path for academic investigators to follow a common protocol and combine clinical trial data to apply for FDA approval. The agency also provided guidance on how FDA intends to apply the 21st Century Cures...