Drugs

De Novo Marketing of 2 Covid Serology Tests

FDA 5/8 granted Ortho-Clinical Diagnostics two de novo marketing authorizations for its Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack for use with the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack for use with the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator. The prescription-only tests are intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma samples collected within 15 days of symptom onset as an aid in identifying those who have an adaptive immune response to SARS-CoV-2 from either a recent or prior infection, according to an FDA release.

“Serology tests detect the presence of antibodies to SARS-CoV-2 and do not detect the virus itself,” the agency explains. “This is one reason that serology tests should not be used to diagnose or exclude acute Covid-19 infection.”

FDA also says the tests’ sensitivity in early infections is unknown, and it says a negative result does not mean that the tested individual is free from an infection, which should be confirmed via a PCR or antigen test for Covid-19.

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