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FDA Approval for Hormones

Meaning

FDA Approval for Hormones refers to the rigorous, multi-stage regulatory authorization granted by the U.S. Food and Drug Administration (FDA) that permits a new hormone drug to be legally marketed and sold in the United States. This formal approval signifies that the drug sponsor has provided substantial evidence demonstrating the medication is both safe and effective for its intended use in the specified patient population. The process is required for all new small-molecule hormone drugs, filed under a New Drug Application (NDA), and for large-molecule biologics, such as peptide hormones, filed under a Biologics License Application (BLA).