As its name suggests, the US Food and Drug Administration, or FDA, regulates drugs and foods. Drugs are subject to extensive review by the FDA. The applicant or “sponsor” must use data from scientific studies to convince the FDA that a drug is safe and effective to treat, cure, diagnose or prevent a disease or condition when used as directed. Drugs require pre-marketing approval by the FDA and cannot be legally marketed and sold in the US until the FDA has approved them.
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