Gene Therapy: Are Patients Any Safer? : Hearing Before the Subcommittee on Public Health of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Sixth Congress, Second Session ... May 25, 2000, Volume 4
United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions. Subcommittee on Public Health
U.S. Government Printing Office, 2000 - Clinical trials - 75 pages
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adenoviral adverse event reporting agencies ASGT Bill Frist Bioethics Biotechnology Center CF Foundation Chairman civil monetary penalties clinical gene transfer clinical investigators clinical research compliance conduct conflict of interest Director disease DNA Advisory Committee DSMB ensure patient safety ethical FDA and NIH Federal gene therapy clinical gene therapy product gene therapy research gene therapy trials gene transfer research gene transfer trials Human Gene Therapy human gene transfer human research subjects Human Services human subjects protection informed consent initiative inspection Institutional Review Board IRBs issues Jesse Gelsinger Johns Hopkins Johns Hopkins Hospital Murray NIH and FDA NIH Guidelines NIH's OPRR patient protection Ph.D Pilaro potential Preclinical protocols Raub Recombinant DNA Advisory recommendations regulations regulatory reporting requirements response risks Senator Dodd Senator Frist Senator Kennedy serious adverse events Skirboll Society of Gene Subcommittee Thank therapy clinical trials tion vectors Zeitlin Zoon