Devices

FDA Posts Performance Data on Antibody Tests

FDA has posted summarized performance data for 12 antibody (serology) tests that have been granted emergency use authorizations (EUA) for detecting the body’s immune response to the Covid-19 infection caused by the virus. About 200 serology tests had been allowed on the market without an EUA, and FDA this week said it was tightening criteria to require test manufacturers to obtain EUAs (see earlier story). The test performance data posted are from those tests that have already gained an EUA.

Serology tests are expected to play a larger role in managing the Covid-19 emergency by helping healthcare professionals identify individuals who have developed an immune response to the virus. In addition, test results can aid in determining who may donate convalescent plasma, which may serve as a possible treatment for those who are seriously ill from Covid-19, FDA says.

FDA also has provided a calculator that will allow users to see the estimated performance of a single test or two independent tests based on their performance characteristics and the estimated prevalence of virus antibodies in the target population.

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