Zdrowie i gospodarka · 15/07/2013
Draft Guidance for Industry on Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans." This draft guidance is intended to provide information to industry on how to submit initial and amended pediatric study plans (PSPs) as required under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA).