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Guidance Issuing OfficeCenter 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.