FDA issues new guidance for oncology drug applications

20 December 2018

The US Food and Drug Administration has issued new guidance related to clinical trial endpoints in oncology, providing recommendations for applicants seeking approval for novel therapies.

The document, available on the FDA website, is titled “Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics.”

The agency says that the updated guidance, which revises and replaces the prior 2007 document of the same name, will “help advance the efficient development of cancer drugs and biologics.”

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