Guidance for Industry: Gene Therapy Clinical Trials -- Observing Participants for Delayed Adverse Events: Draft Guidance
Center for Biologics Evaluation and Research [CBER] (United States)
Rockville, MD: Center for Biologics Evaluation and Research [CBER] (United States), 2005 August; 23 p. [Online]. Available: http://www.fda.gov/cber/gdlns/gtclin.pdf [2006 May 3]
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