Drugs

FDA Recognizes Molecular Tumor Marker Database

FDA has granted recognition to a partial listing of the Memorial Sloan Kettering Cancer Center Oncology Knowledge Base as the first tumor mutation database to be included in the Public Human Genetic Variant Databases. An agency announcement says FDA recognized a portion of the database as a source of valid scientific evidence for Level 2 (clinical significance) and 3 (potential clinical significance) biomarkers. Under FDA’s database recognition program, test developers can use the data to support the clinical validity of tumor profiling tests in premarket submissions, the notice says.

The database contains detailed information about specific alterations in 682 cancer genes. The information reportedly is curated from various worldwide sources, including government agencies, medical professional groups, medical and scientific literature, and clinical trials.

FDA says it reviewed the operating and governance procedures and policies, processes for the database and for variant evaluation and curation, and method of assignment of clinical significance.

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