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February 16, 2024

Drug Trials Snapshots: AGAMREE

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]
February 16, 2024

Data Standards Program Strategic Plan and Board

Strategic Plan CDER’s approach to data standards consists of four strategic goals: Support open, consensus-based data standards development Maintain and promote a well-defined data standards governance […]
February 16, 2024

Newly Added Guidance Documents

Procedural Charging for Investigational Drugs Under an IND: Questions and Answers Final 2/14/2024 Clinical – Medical Use of Data Monitoring Committees in Clinical Trials Draft 2/13/2024 […]
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