Why Most Regenerative Therapy Applications for US RMAT Designation Fail to Make The Grade
“It didn’t take long for folk to start applying,” a US Food and Drug Administration official says of the 17 applications the agency has received so far for designation under its new regenerative medicine advanced therapy (RMAT) program for fostering the development of such products.
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CBER's Rachael Anatol says such a situation has happened "more than a few times"; instances appear to have been largely concentrated in earlier days of the RMAT program.
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