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FDA Standards

Meaning

FDA Standards are the comprehensive regulatory requirements and guidelines established by the U.S. Food and Drug Administration for the development, testing, manufacturing, labeling, and marketing of pharmaceutical drugs, medical devices, and certain food products. These standards ensure that products are proven to be safe and effective for their intended use before they reach the public. Adherence to these protocols, including Good Clinical Practice and Good Manufacturing Practice, is mandatory for clinical translation and commercialization within the United States. They serve as a critical benchmark for clinical rigor and patient protection.