Submit Comments by 12/17/2024
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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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-3993
Docket Number: FDA-2024-D-3993 Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Postoperative Nausea and Vomiting: Developing Drugs for Prevention.” This guidance provides recommendations regarding the design of clinical trials for the prevention of postoperative nausea and vomiting in adults, including considerations for eligibility criteria, trial design features, efficacy evaluations, and safety assessments.
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Content current as of:
10/18/2024
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