GUIDANCE DOCUMENT
Evaluating Cancer Drugs in Patients with Central Nervous System Metastases Guidance for Industry July 2021
- 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.
Submit Comments
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
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All written comments should be identified with this document's docket number: FDA-2020-D-0938.
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