The FDA's proposal for public disclosure of adverse events in gene therapy trials
Barnbaum, Deborah R.
Politics and the Life Sciences 2000 September; 19(2): 261-268
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Guidance for Industry: Gene Therapy Clinical Trials -- Observing Participants for Delayed Adverse Events: Draft Guidance Center for Biologics Evaluation and Research [CBER] (United States) (2005-08)