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Guidance Title Issue Date FDA Organization Topics Status
Institutional Review Boards Frequently Asked
Questions: Guidance for Institutional
Review Boards and Clinical Investigators		 2025-02-05 OC\Office of the
Chief Medical
Officer\Office of
Clinical Policy		 Good Clinical Practice
(GCP), Pediatric
Product Development		 Final
Evaluation of Sex Differences in Clinical
Investigations: Guidance for Industry		 2025-01-20 OC\Office of the
Chief Medical
Officer\Office of
Clinical Policy		 Good Clinical Practice
(GCP)		 Final
Recommendations to Reduce the Risk of
Transfusion-Transmitted Malaria: Draft
Guidance for Industry		 2025-01-15 CBER Blood, Blood Products Draft
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