NIH proposal to change Recombinant DNA Advisory Committee rule provisionally accepted.

Executive Summary

GENE THERAPY PROTOCOL APPROVAL AUTHORITY WOULD BE SOLELY FDA RESPONSIBILITY, under a proposal provisionally approved by the National Institutes of Health's Recombinant DNA Advisory Committee Dec. 9. RAC gave provisional approval to NIH's latest proposal to restructure the policy body, as outlined in a Nov. 22 Federal Register notice. Under the proposal, RAC's membership would be reduced from 25 to 15 and the committee would cede sole protocol approval authority to FDA ("The Pink Sheet" Nov. 25, T&G-6).