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FDA Regulations

Drug Approval Process Vaccine Labeling Quality Control Product Recalls Drug Approval Processes Clinical Holds Clinical Trial Approvals 505(b)(2) Pathway Vaccine Approval Process Risk Evaluation and Mitigation Strategy

FDA Approves Aqvesme for Thalassemia Anemia, First U.S. Therapy for Both Patient Groups

Approval reflects late-stage efficacy results with use restricted under a REMS requiring frequent liver tests.

Trump Administration Begins Enforcing Prescription Drug Price Controls