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How to Conduct Effective Generic Drug Clinical Studies

The FDA ensures the safety and effectiveness of generic drugs by rigorously reviewing and approving them. This process includes doing bioequivalence trials to compare the active ingredient’s performance in the generic drug and its brand-name version, adhering to region-specific regulatory requirements, conducting clinical trials, ensuring high-quality manufacturing, and continuously monitoring drug quality. Generic drug manufacturers can expedite the approval process by studying FDA guidelines early and regularly consulting with the FDA.

Source: www.drugpatentwatch.com –

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