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FDA Drug Assessment

Meaning

FDA Drug Assessment is the rigorous, multi-phase regulatory process conducted by the U.S. Food and Drug Administration (FDA) to determine the safety and efficacy of a new pharmaceutical product before it can be legally marketed in the United States. This comprehensive evaluation requires manufacturers to submit extensive data from pre-clinical studies, clinical trials, and detailed information regarding the drug’s manufacturing, labeling, and proposed use. The assessment aims to ensure that the drug’s potential benefits for the target population outweigh its known risks, adhering to the agency’s mandate to protect public health. The process culminates in either approval, which permits marketing, or a complete response letter, which denies approval pending further data.