Department of Health and Human Services May 19, 2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention.'' This guidance addresses FDA's current thinking regarding clinical trials for drugs for the prevention of chemotherapy-induced nausea and vomiting (CINV) in adults, including recommendations for trial population, trial design, efficacy considerations, and clinical outcome assessments. This guidance details a recent change in our recommendations regarding the necessary evidence and recommended endpoint assessments needed to support a determination of efficacy for the indication of the prevention of CINV. Previously, drug development programs seeking an indication for the prevention of CINV typically selected a primary efficacy endpoint of complete response, defined as no vomiting and no use of rescue antiemetic medication, with additional direct evaluation of nausea frequency and severity positioned as exploratory assessments. To promote consistency and interpretability in the assessment of nausea both within and across development programs, FDA now recommends sponsors analyze a primary endpoint of complete response (i.e., a binary endpoint defined as no vomiting and no use of rescue antiemetic medication) and a secondary endpoint of the absence of nausea (i.e., a binary endpoint defined as no reported nausea and no use of rescue antiemetic medication) by evaluating the difference in the proportions of responders across treatment arms to establish efficacy for the prevention of CINV.

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.