NIH Ends Gene Therapy Trial Reporting Requirements In Reg Streamlining Move
Trial protocols, annual reports, and adverse event reports on gene therapies will only go to US FDA under now-finalized amendments, a sign that the product category is maturing and can be regulated like other drugs and biologics.
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NIH Director Francis Collins describes evolution of existing collaborations and how the two agencies might facilitate development of gene therapy, such as by having a common template for regulatory review.
Streamlining adverse event reports among reform ideas; NIH's Recombinant DNA Advisory Committee likely to drop review of more routine protocols.
INTERACT program will allow sponsors to ask FDA questions about manufacturing and other technical issues to help streamline development.