NIH-FDA Gene Therapy Trial Adverse Event Reporting Study Under Way
Executive Summary
NIH and FDA will conduct a comparative analysis of "the number of serious adverse events in human gene therapy trials reported to each agency," outgoing NIH Director Harold Varmus, MD, said in a Dec. 1 letter to Senate Health/Public Health Subcommittee Chair Frist (R-Tenn.).
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Gene therapy hearing
Senate HELP/Public Health Subcommittee Chair Bill Frist (R-Tenn.) plans to hold a gene therapy oversight hearing Jan. 26. Although the witness list has not been finalized, it is expected to include representatives from the National Institutes of Health and FDA. Frist has been looking into the deaths of patients in gene therapy trials (1"The Pink Sheet" Dec. 6, 1999, p. 13)
Gene therapy hearing
Senate HELP/Public Health Subcommittee Chair Bill Frist (R-Tenn.) plans to hold a gene therapy oversight hearing Jan. 26. Although the witness list has not been finalized, it is expected to include representatives from the National Institutes of Health and FDA. Frist has been looking into the deaths of patients in gene therapy trials (1"The Pink Sheet" Dec. 6, 1999, p. 13)
Gene Therapy Protocol Linked To Death Was Altered At FDA - RAC's Walters
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