Drugs

Biomarker Evidentiary Criteria Framework Released

The Foundation for the National Institutes of Health 12/6 released its Framework for Defining Evidentiary Criteria for Biomarker Qualification, developed in collaboration with FDA, NIH, the Critical Path Institute, PhRMA and numerous drug companies, including Genentech, Merck, Pfizer and Takeda. The 44-page document incorporates input from nearly 200 scientific leaders in the field. “It’s hard to overestimate the potential impact of the work that is being done here,” CDRH director Janet Woodcock, said about this effort during her keynote address at an April 2016 workshop on this topic.

According to a foundation announcement, progress in the use of biomarkers in drug development has been hampered by the lack of clear, predictable and specific regulatory criteria for the evidence required to qualify new markers. The Framework document seeks to address these issues through a defined framework that suggests biomarker developers focus on five specific steps: describing a statement of need, defining a specific context of use, performing a benefit analysis, performing a risk analysis and concisely describing available evidence. It is hoped that the framework will promote collaborative discussions between biomarker developers and the FDA, improve upon the quality of biomarker qualification submissions to the FDA and inform future FDA efforts to develop relevant guidance for evidentiary criteria in biomarker qualification.

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