Sunday, July 09, 2017 2:55:16 PM
From the latest updates i`ve found the 21st Century Cures Act with FDA now has established the new designation for regenerative medicines part of it`s legislature, known as the regenerative medicine advanced therapy (RMAT) designation. As of late June 2017 there have been 19 requests for RMAT designations, 18 of which CBER has acted on and 4 that have been granted. Being this agency is still so new and the designation for regenerative medicines part is the newest add on to the 21st Century Cures Act I can not find anything on it regarding individual companies. Also you can be sure the company itself would release news if anything happens or they have applied for it.
From March filing:
Under the United States 21st Century Cures Act, MPC-150-IM may be eligible for regenerative medicine advanced therapy (RMAT) designation for treatment of advanced and/or end-stage CHF in adults and children. Such designation may facilitate accelerated approval pathways for this product candidate.
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