Process for Handling Referrals to FDA Under 21 CFR 5054 - Additional Safeguards for Children in Clinical Investigations: Guidance for Clinical Investigators, Institutional Review Boards and Sponsors
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
December 1, 2006
August 10, 2024
57b4b090-bd0e-4212-a631-6ebc41223136
Related Documents
Frequently Asked Questions - IRB Registration: Guidance for Institutional Review Boards (IRBs)
Guidance DocumentJuly 9, 2009Office of the Commissioner
Voting Procedures for Advisory Committee Meetings: Guidance for FDA Advisory Committee Members and FDA Staff
Guidance DocumentAugust 1, 2008Office of the Commissioner
Preparation and Public Availability of Information Given to Advisory Committee Members: Guidance for Industry
Guidance DocumentAugust 1, 2008Office of the Commissioner
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox