Process for Handling Referrals to FDA Under 21 CFR 50.54 - Additional Safeguards for Children in Clinical Investigations: Guidance for Clinical Investigators, Institutional Review Boards and Sponsors
Information
Type
Guidance
Regulated products
Biologics, Drugs, Medical Devices
Topics
Good Clinical Practice (GCP), Pediatric Product Development
Published
December 1, 2006
Last updated
August 9, 2024
Description
This document is a guidance document titled "Process for Handling Referrals to FDA Under 21 CFR 50.54" that provides additional safeguards for children in clinical investigations. It focuses on Good Clinical Practice (GCP).
Tags
Organization
Country / Region
United States
License
Other (Public Domain)