BRIEF—FDA finalizes guidance on regenerative medicines

The US Food and Drug Administration (FDA) on Friday 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 clarifies how the FDA will evaluate devices used in the recovery, isolation or delivery of regenerative medicine advanced therapies (RMATs).

The second final guidance, describes the expedited programs that may be available to sponsors of regenerative medicine therapies for serious conditions, including the new RMAT designation created by the 21st Century Cures Act, Priority Review designation and Accelerated Approval.

In addition, the guidance describes the regenerative medicine therapies that may be eligible for RMAT designation.