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Federal Food Drug and Cosmetic Act (FFDCA) Product Development Protocols

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FDA Issues Supplemental Notice of Proposed Rulemaking and Draft Guidance Regarding Inclusion of Pediatric Subpopulation...

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On February 19, 2013, FDA issued a supplemental notice of proposed rulemaking in the Federal Register, re-proposing amendments regarding information about pediatric subpopulations that must be submitted for certain medical...more

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