Drugs

CDER, C-Path Acute Kidney Injury Project

The Critical Path Institute (C-Path) is joining the CDER Office of Translational Science and the Division of Cardiology and Nephrology in an Acute Kidney Injury (AKI) Project to develop a suite of prognostic tools to improve the prediction and detection of drug-induced kidney injury (DIKI). A C-Path statement says an Acute Kidney Injury Working Group has been established with representation from FDA, the National Institute of Diabetes and Digestive and Kidney Diseases, the American Society of Nephrology and Kidney Health Initiative, representatives from academic research programs and the pharmaceutical industry, and individuals living with AKI.

One of the working group’s near-term deliverables is to convene a public workshop dedicated to identifying how academia, health authorities, patient advocates, and the pharmaceutical industry can collaborate and share knowledge from past and future studies to generate novel tools, including systems that allow for an accurate simulation of kidney injury in the lab and computers, as well as non-invasive tests for patients, the notice says.

“The AKI project will focus primarily on the development of predictive tools for DIKI, but it is anticipated this initiative will also feed into, synergize with, and offer support for current and future efforts to develop tools to advance drug development for other causes of AKI and ultimately improve the care of AKI patients,” C-Path says.

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