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U.S. Department of Health and Human Services


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Cancer Drugs

The Food and Drug Administration has undertaken a project to evaluate potential endpoints for cancer drug approval. Endpoints were examined for the most common cancers, such as lung cancer, colon cancer, etc. For each cancer, FDA held public workshops to identify important issues, and these issues were discussed in meetings of the Oncologic Drugs Advisory Committee (ODAC). Subsequently, guidance documents will be published describing FDA's current thinking on endpoints for cancer drug approval.