FDA/NIH CONSOLIDATED REVIEW PROCEDURE ADOPTED BY rDNA CMTE.; FDA DEVELOPING GENE THERAPY PROTOCOL DATABASE; FDA PRECLINICAL SAFETY OVERVIEW PRESENTED
Executive Summary
The proposal to consolidate FDA gene therapy protocol reviews with those conducted by the National Institutes of Health was unanimously adopted by the NIH Recombinant DNA Advisory Committee (RAC) at its March 6-7 meeting in Bethesda, Md. The process will be implemented following NIH Director Harold Varmus' approval, but it does not require formal FDA approval.