Guidance for Industry. Qualifying for Pediatric Exclusivity Under Section 505A of211 the Federal Food, Drug, and Cosmetic Act (Revised)

摘要

;Partial Contents: Why is FDA issuing this guidance; How does a new drug211u001eapplication quality for pediatric exclusivity; What are pediatric studies; What 211u001eis an FDA written request for pediatric studies; How do I obtain a written 211u001erequest; What is the content of a written agreement for the conduct of pediatric 211u001estudies; What are commonly accepted scientific principles and protocols; How do I 211u001efile my reports of studies with FDA.