Submit Comments by 10/20/2025
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document’s docket number: FDA-2024-D-5850
Docket Number: FDA-2024-D-5850 Issued by:
Guidance Issuing Office
Oncology Center of Excellence
The purpose of this guidance is to provide recommendations to sponsors on the assessment of overall survival in randomized oncology clinical trials conducted to support marketing approval of drugs and biological products, with an emphasis on the analysis of overall survival as a pre-specified safety endpoint. While the guidance discusses situations in which it is appropriate to consider overall survival for the primary endpoint, this guidance primarily focuses on statistical or design considerations when overall survival is not the primary endpoint. Additionally, this guidance focuses on the assessment of overall survival in randomized trials.
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Content current as of:
08/18/2025
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Regulated Product(s)
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