Devices

FDA Covid-19 Serology Tests Lessons Learned

CDRH director Jeffrey Shuren and Office of In Vitro Diagnostics and Radiological Health director Timothy Stenzel say that knowing what they know now, they would not have permitted SARS-CoV-2 serology tests to be marketed without FDA review and authorization. Writing in a New England Journal of Medicine Perspective, Shuren and Stenzel list five lessons learned from the agency’s experience with Covid-19 serology tests that flooded the market after some government officials touted their use in reopening the economy and insurance coverage was provided for some uses not supported by science:

it is important to authorize medical products independently, based on sound science, and not permit market entry of tests without authorization;
the federal government should coordinate the preparation of a public/private research plan to address epidemiologic questions about disease spread and immunity at the beginning of an outbreak as part of its preparedness plan;
capacity should be established within or on behalf of the federal government to evaluate test performance before outbreaks occur so that independent evaluation can be performed quickly during an outbreak;
the scientific and medical communities should understand the purpose and clinical use of serology tests and how to appropriately use test results in general to inform patient care; and
all parties involved in public health emergency response need better information more quickly.

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