Business · 20/12/2017Updated: 10/17/2026 · 1 min read
FDA Announces Changes to Orphan Drug Designation for Pediatric Subpopulations of Common Diseases
Summary
The FDA is releasing a draft guidance to clarify its orphan drug designation policy for pediatric subpopulations of common diseases, aiming to prevent a loophole that allowed sponsors to bypass required pediatric studies
Original source language: Federal Register — Food and Drug AdministrationOpen original release →