What Process Do Pending FDA Drug Approvals Go Through?


Quick Answer

Every new drug follows a unique path from preclinical animal testing to final approval for sale in the United States, according to the U.S. Food and Drug Administration. Despite the variability in the process, approval generally follows a seven-stage path to ensure safety and effectiveness.

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Full Answer

Before the FDA reviews a new drug, manufacturers often carry out their own animal trials to establish the effect they hope the drug has on animal physiology. During this preliminary phase, drug makers frequently seek guidance from the FDA on the sort of data the agency requires for the particular drug under consideration, according to the FDA. Once the guidelines are met, the FDA assembles a panel to approve the testing protocols and the parameters of future trials, most of which take place in hospitals and field settings.

Drug trials proceed in three phases, notes the FDA. Phase 1 trials involve between 20 and 80 healthy subjects, to get a picture of the drug's most common side effects. If this phase reveals no pressing safety issues, phase 2 trials study the drug's effectiveness, using the same sampling methods of the previous phase. If the drug appears to be both safe and effective, researchers calculate a recommended dose using very large phase 3 trials involving hundreds or thousands of subjects. Finally, the FDA and the drug's sponsor review the results, and the application goes to final approval by the administration. This review usually returns either an approval or rejection within 10 months.

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