Clinical Trials. Clinical Trial New Drug Development Timeline. Source: FDA/Center for Drug Evaluation and Research www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm053131.htm. Clinical Trials. Research and Development
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Source: FDA/Center for Drug Evaluation and Research
Research and Development
Investigational New Drug Application
Testing the various doses of the drug and dosing regimens
For example, of 100 drugs for which investigational new drug applications are submitted to the FDA, about 70 percent will clear Phase 1 and go on to Phase 2. About 33 of the original 100 drugs will clear Phase 2 and go on to Phase 3. About 25 to 30 of the original 100 drugs will clear Phase 3 and go on to Phase 4. Finally, on average, 20 of the original 100 drugs ultimately will be approved for marketing. www.centerwatch.com/clinical-trials/overview.aspx