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Guidance on Pediatric Study Plans

07/15/2013

Federal Register Notice: FDA is making available a draft guidance for industry entitled Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans. It is intended to provide information to industry on how to submit initial and amended pediatric study plans as required under the FD&C Act as amended by the Food and Drug Administration Safety and Innovation Act. To download this guidance, click here. To view this notice, click here.

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