FDA, NIH look to streamline oversight of gene therapies
The FDA and NIH are proposing to further limit the role of the NIH and its Recombinant DNA Advisory Committee (RAC) in the review of human gene therapies.
The changes, announced in the Federal Register on Thursday, are aimed at reducing overlaps in the two agencies’ oversight of gene therapies which result in duplicative work for sponsors as the field progresses following the approval of the first three gene therapies last year.
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.