Ac­cel­er­at­ed ap­proval will be 'the nor­m' for gene ther­a­pies, FDA's Pe­ter Marks says

The FDA will in­creas­ing­ly use ac­cel­er­at­ed ap­proval for gene ther­a­pies aimed at rare con­di­tions, ac­cord­ing to Pe­ter Marks, the FDA’s top of­fi­cial over­see­ing cell and gene ther­a­pies, the clear­est sig­nal yet of how wide­ly the agency will de­ploy its ex­pe­dit­ed path­way.

Marks’ com­ments, made last week at a work­shop in Wash­ing­ton, build on a stance he took last year back­ing ac­cel­er­at­ed ap­proval for gene ther­a­pies, which of­ten tar­get young chil­dren with ul­tra-rare con­di­tions.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER