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Drug Approval Process

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alchemist04's version from 2018-03-19 21:45

FDA's Drug Approval Process

StepsProcessNo of Potential drugsNo of yearsStages of Approval
1Drug Discovery Lab Research5,000 - 10,0002-10 yearsPre-Clinical
2Pre-Clinical Research/Animal Testing~2503-6 yearsPre-Clinical And IND Application
3Clinical Trials/3 phases20-5,000 subjects6-7 yearsClinical
4FDA Review1 approved drug1-2 yearsNew Drug Application (Drug labelling, Application reviewed, NDA Application, Review meeting, Facility Inspection)
5Ongoing Analysis1 approved drugThe life of the drugFDA Approval & Risk management, Phase 4 (Post-Marketing)
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