Draft Guidance Covers Pediatric Study Plan Submission By New Drug, Biologic Sponsors

Sponsors of marketing applications for new drug or biologic products would be required to submit pediatric study plans (PSP) no later than 60 days after meeting with the Food and Drug Administration at the end of a phase II study if the application is subject to the Pediatric Research Equity Act, according to a draft guidance released July 15 by the agency.

FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research announced the draft guidance, Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans, in ...