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Regenerative Medicine Therapies: Manufacturing Changes May Not Impact RMAT Designation

Executive Summary

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.

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RMAT Designation Requests May Rise Or Fall On Manufacturing Changes, Clinical Data Breadth

Product characterization questions and partial or inconsistent clinical data are among the more common reasons why the US FDA denies, or seeks additional information about, a request for regenerative medicine advanced therapy designation, FDA’s Bryan says; sponsors should consider why they are seeking designation when deciding whether to apply for RMAT, breakthrough therapy or both.

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