Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections: Draft Guidance for Institutional Review Boards, Investigators, and Sponsors
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
March 30, 2023
April 11, 2024
26eaec4e-0434-4c59-a182-47818d614186
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