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Drug Regulation

Review By The U.s. Food And Drug Administration

The FDA evaluates the data presented from the clinical trials in the New Drug Application (NDA) submitted by the manufacturer. The application consists of the application form and data from preclinical testing, chemistry and manufacturing data, clinical trials, samples and product labeling, and relevant publications.

The FDA evaluates the safety and efficacy of the drug and the quality of the data supporting the claims being made by the manufacturer. If approved, the product goes to market and enters Phase IV clinical trials.

Additional topics

Medicine EncyclopediaAging Healthy - Part 1Drug Regulation - Discovery, Preclinical Testing, Phase I, Phase Ii, Phase Iii, Review By The U.s. Food And Drug Administration - Phase IV, Time and cost