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GUIDANCE DOCUMENT

Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention Guidance for Industry Draft Guidance for Industry May 2021

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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-2021-D-0351


Docket Number:
FDA-2021-D-0351
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to help sponsors in the clinical development of drugs for the prevention of chemotherapy-induced nausea and vomiting (CINV) in adults. Specifically, this guidance addresses FDA’s current recommendations on clinical trials for drugs being developed under Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355) and 21 CFR Parts 312 and 314 for the prevention of CINV and considerations for eligibility criteria, trial design features, efficacy evaluations, and clinical outcome assessments.

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