FDA Inspections of Phase 1 Clinical Units in the United States
FDA Inspections of Phase 1 Clinical Units in the United States FDA Oversight of Phase 1 Clinical Units in U.S. Clinical Research Introduction Phase 1 clinical trials mark the first-in-human testing of investigational drugs and biologics, making them a critical juncture for ensuring safety, ethics, and regulatory compliance. In the United States, Phase 1 units—including…
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