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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

The gene therapy protocol implicated in the September death of an Arizona patient was modified during FDA review after the study was approved by the NIH Recombinant DNA Advisory Committee, panel members who evaulated the trial assert.

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