Gene Therapy Trials Could Be Halted If Public Disclosure Is Not Made - FDA
Executive Summary
FDA's gene therapy disclosure proposal would permit the agency to impose a clinical hold on trials if a sponsor fails to submit a redacted version of information for public disclosure.
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Gene therapy
FDA Biological Response Modifiers Advisory Committee will discuss agency's proposed rule on public disclosure of gene therapy trials at April 5-6 meeting (1"The Pink Sheet" Jan. 22, p. 23). The committee will review results from gene therapy clinical site inspections and long-term follow-up of gene therapy patients. The meeting will take place at the Holiday Inn in Bethesda, Md., beginning at 9 a.m. on April 5 and 8:30 a.m. on April 6