Guidance for Industry: How to Comply With the Pediatric Research Equity Act: Draft Guidance
Rockville, MD: U.S. Food and Drug Administration [FDA], 2005 September; 18 p. [Online]. Accessed: http://www.fda.gov/cber/gdlns/pedreseq.pdf [2006 May 3]
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Center for Drug Evaluation and Research [CDER] (United States) Center for Biologics Evaluation and Research [CBER]
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Guidance for Industry: Gene Therapy Clinical Trials -- Observing Participants for Delayed Adverse Events: Draft Guidance Center for Biologics Evaluation and Research [CBER] (United States) (2005-08)