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RAC balks at regulatory reforms. (Recombinant DNA Advisory Committee)

AIDS Weekly

| December 19, 1994 | COPYRIGHT 2009 NewsRX. (Hide copyright information)Copyright

The proposed streamlining of U.S. federal review of proposals for gene therapy research - a summer 1994 agreement that would have given approval authority over such undertakings exclusively to the U.S. Food and Drug Administration (FDA) - appears to have broken down.

Such reviews have traditionally been conducted by both the FDA and the U.S. National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC), and several members of the RAC have balked at approving the agreement, contending that the committee's public reviews of proposed research should continue.

Further, the Foundation on Economic Trends (FET), Washington, D.C., threatened to sue if …

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