Drugs

CDER Wants Info for Kidney Safety Biomarker Pilot

CDER is requesting information for a planned regulatory science initiative to advance biomarker validation through the compilation of data from multiple sources and through a specific pilot project focused on aggregating data for biomarkers of drug-induced kidney injury. A 5/13 Federal Register notice says ultimately, improving CDER’s ability to evaluate novel biomarkers could facilitate the generation of higher-quality biomarker data, expanded use of novel biomarkers, more consistent interpretation of findings from biomarker studies, and development of novel endpoints that can support a range of regulatory and drug development decisions.

The notice says that under this Biomarker Incubator initiative, the agency has focused on advancing the use of biomarkers of drug-induced kidney injury as a pilot project. It says the project’s specific objectives are to:

assess data availability and quality;
pool data from a range of clinical trial participants, drug programs, and phases of development;
perform analyses characterizing intersubject and intrasubject variability, expected ranges for subpopulations, time-course for changes, use and quality of different assay methodologies, and the predictive performance compared to conventional biomarkers; and
establish a process and platform for identifying, requesting, receiving, storing, and analyzing data to support biomarker use in drug development.

“This request for information aims to provide an opportunity for stakeholders — including both commercial drug developers and academic investigators — to share with FDA deidentified subject-level data on these biomarkers and experiences and challenges in applying these biomarkers in drug development,” the notice 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