Docket Number:
FDA-2020-D-0938
Issued by:
Guidance Issuing Office
Oncology Center of Excellence
Center for Drug Evaluation and Research
Office of the Commissioner

The purpose of this guidance is to describe FDA’s recommendations for clinical trial designs of cancer drugs or biological products regulated by CDER and CBER that are intended to support product labeling describing the antitumor activity in patients with central nervous system (CNS) metastases from solid tumors originating outside the CNS.

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All written comments should be identified with this document's docket number: FDA-2020-D-0938.

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