Pediatric Study Plans – Draft Guidance FDA
Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans – Guidance for Industry
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Pediatric Study Plans – Draft Guidance
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
March 2016
Procedural Revision 1
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
March 2016
Procedural Revision 1