FDA Seeks To Advance Gene Therapy With Six Draft Guidances

FDA published a suite of six gene therapy draft guidances on Wednesday (July 11) -- three of which are disease-specific while the other three focus on manufacturing and patient follow-ups -- following through on FDA Commissioner Scott Gottlieb's promise last year to issue the documents as part of a comprehensive policy to advance the field of gene therapy. FDA unveiled a risk-based framework for regenerative medicine in November, which proposed what Gottlieb described as a "novel and modern" approach to...