Friday, October 30, 2020

FDA CDER Impact Story: A CDER Study of Factors that May Predict the Likelihood of Generic Drug Marketing Applications - Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information
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FDA CDER Impact Story: Real-world equivalence, just like clinical trial data, confirms that generic drugs are therapeutically equivalent to brand-name drugs

Increasing generic drug competition can help patients to have access to more affordable therapies, which is a critical part of the CDER mission. CDER investigations identify drug and regulatory characteristics that appear to facilitate generic drug development.

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