Enzyvant RMAT

Mesoblast gets FDA RMAT; List of 10 total designations so far

December 26, 2017 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 13 Comments

Australian stem cell biotech Mesoblast announced that it has received regenerative medicine advanced therapy (RMAT) designation from the U.S. FDA. This is very good news for the company and an encouraging development for the field. Interestingly, last month the FDA clarified that there is expanded RMAT designation that can include gene therapies too. At the Meeting …

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Big change for stem cell field with FDA quickly issuing RMATs

May 5, 2017 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 2 Comments

The 21st Century Cures Act has some important regenerative medicine language in it. One part of that was attempting to accelerate FDA review of promising investigation regenerative medicine therapies. The mechanism for this was a new designation called Regenerative Advanced Therapy, now renamed Regenerative Medicine Advanced Therapy (RMAT) Designation. I don’t think anyone was sure …

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