drug discovery - what happens after fda approval?

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Drug Discovery - What Happens after FDA Approval?

Drug Discovery - What Happens after FDA Approval? By Lindsay RosenwaldIntroductionIn the current drug discovery models, prospective compounds must clear a battery of early safety tests and clinical trials before earning approval from the Food and Drug Administration. Once a drug finally completes Phase 3 trials and demonstrates high levels of safety and efficacy in large groups of patients, it undergoes official review by the FDA and earns approval for distribution. FDA ApprovalWhen a drug receives final FDA approval, pharmaceutical companies can begin manufacturing the substance on a large scale. In many cases, this involves the construction of new facilities to meet the sharp uptick in production. All facilities must meet the standards set forth by the FDA Current Good Manufacturing Practices.

ConclusionOn the clinical side, new medications almost always undergo Phase 4 trials, which focus primarily on the long-term effects of the drug or how the drug affects a particular subset of patients. If a pharmaceutical company discovers an adverse reaction in Phase 4 trials, it must submit a report to the FDA.