Friday, February 15, 2019

FDA advances new efforts to promote development of safe and effective regenerative medicine products

Today, the FDA finalized two guidance documents regarding regenerative medicine therapies. Both documents were first issued in draft in November 2017 as part of a suite of guidances that comprised the FDA’s comprehensive regenerative medicine policy framework.

The first final guidance, Evaluation of Devices Used with Regenerative Medicine Advanced Therapies,which is required by the 21st Century Cures Act, clarifies how the FDA will evaluate devices used in the recovery, isolation or delivery of regenerative medicine advanced therapies (RMATs). The guidance specifies that devices intended for use with a specific RMAT may, together with the RMAT, be considered to comprise a combination product.

The second final guidance, Expedited Programs for Regenerative Medicine Therapies for Serious Conditions, describes the expedited programs that may be available to sponsors of regenerative medicine therapies for serious conditions, including the new Regenerative Medicine Advanced Therapy (RMAT) designation created by the 21st Century Cures Act, Priority Review designation andAccelerated Approval. In addition, the guidance describes the regenerative medicine therapies that may be eligible for RMAT designation.  

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