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.
Drug companies have their last chance to negotiate which documents and information Italy’s regulator, AIFA, will be entitled to request of them when they submit pricing and reimbursement applications.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.