Devices

AdvaMedDx Comments on FDA Viral Mutation Impact Guidance

AdvaMedDx says its members develop in vitro diagnostic tests that facilitate evidence-based medicine, improve quality of patient care, enable early detection of disease, and reduce overall healthcare costs. In comments on an FDA guidance, Policy for Evaluating Impact of Viral Mutations on Covid-19 Tests, the association says its members “anticipate virus mutations and, when designing tests, strive to target multiple areas of the viral genome, focusing on those sites that are least likely to mutate, in an effort to ensure such tests work for variants.”

The letter contains overall recommendations on these topics: FDA/industry partnership, appearance of sequences in public databases may not directly correspond with prevalence and level of clinical concern, utilization of in silico analysis, transparency and flexibility in protocols and reporting results, and different types of assays trigger different considerations.

It also has recommendations specific to molecular tests, antigen tests, T-cell tests, and serology tests.

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