Drugs

Draft Guide on Chemo-induced Nausea Drugs

Federal Register notice: FDA has made available a draft guidance entitled Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention. The document provides recommendations for trial population, trial design, efficacy considerations, and clinical outcome assessments. It was developed to detail a recent change in agency recommendations on the necessary evidence and recommended endpoint assessments needed to support an efficacy determination for chemotherapy-induced nausea and vomiting indications. Previously, drug development programs seeking such indications 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 preventing nausea and vomiting. To view the notice, click here.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome