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FDA Requirements

Meaning

FDA Requirements refer to the comprehensive and mandatory set of regulations, detailed guidelines, and specific statutes enforced by the U.S. Food and Drug Administration (FDA) for the manufacturing, rigorous testing, precise labeling, and ethical marketing of pharmaceutical drugs, medical devices, and all other regulated health products. These requirements are fundamentally designed to ensure that every product sold to the public has been conclusively proven to be both safe and effective for its stated intended use. Compliance necessitates strict adherence to Good Manufacturing Practices (GMP), the submission of extensive clinical and non-clinical data for New Drug Applications (NDA), and ongoing post-market surveillance activities. For compounding pharmacies, specific sections of the Food, Drug, and Cosmetic Act govern their quality standards and operational scope.