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
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