Business · 11/04/2018Updated: 10/17/2026 · 1 min read
FDA Publishes Guidance on Clinical Investigation of Medicinal Products in Pediatric Population
Summary
The FDA has released an updated guidance, E11(R1) Addendum, which provides clarification and current regulatory perspective on pediatric drug development, building on the 2000 guidance ICH E11 (2000)
Original source language: Federal Register — Food and Drug AdministrationOpen original release →