GUIDANCE DOCUMENT
Evaluating Cancer Drugs in Patients with Central Nervous System Metastases Draft Guidance for Industry August 2020
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2020-D-0938
- Issued by:
-
Guidance Issuing OfficeOncology Center of ExcellenceCenter for Drug Evaluation and ResearchOffice 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.
FDA’s current thinking regarding inclusion of patients with brain metastases in clinical trials is addressed in the guidance for industry Cancer Clinical Trial Eligibility Criteria: Brain Metastases.
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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
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Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-0938.