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Regenerative Medicine Therapies: Manufacturing Changes May Not Impact RMAT Designation

 
• By Brenda Sandburg

Final guidance notes that preliminary clinical evidence may come from studies conducted outside the US, says historical controls may be considered in clinical trial designs.

3D Human or animal Cell

US FDA made minor tweaks to its draft guidance for development of regenerative medicine therapies, clarifying that historical controls may be considered in clinical trials, that sponsors may receive more than one regenerative medicine advanced therapy (RMAT) designation for a product, and that manufacturing changes to products would not necessarily preclude an initial RMAT designation or cause it to be rescinded.

The agency's final guidance, Expedited Programs for Regenerative Medicine Therapies for Serious Conditions, includes few changes to the draft guidance issued in November 2017. FDA addressed several recommendations made...

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