Devices

Lab Tests Could be in Preparedness Bill

A Roll Call analysis of efforts to date to develop a pandemic preparedness reauthorization bill indicates that FDA oversight of laboratory-developed diagnostic tests is likely to be part of the debate. The article says the effort to strengthen FDA oversight was dropped at the end of 2022 amid House procedural concerns and industry pushback on impacts on academic medical centers.

A standalone bill was reintroduced recently by Reps. Larry Buschon (R-IN) and Diana DeGette (D-CO). “What’s going to happen is, if we don’t do this legislatively, FDA is going to do something, right?” Buschon said. “And my preference always is to have a legislative process.”

FDA does plan to move forward, according to CDRH director Jeffrey Shuren. In a recent interview with the Alliance for a Stronger FDA, Shuren said, “We think it’s vitally important for spurring innovation and doing responsible innovation. New doesn’t matter if it really doesn’t work, or doesn’t work well.”

Roll Call says AdvaMed has lobbied for the increased agency oversight, which its diagnostics members already undergo. But the lab industry has signaled it could challenge FDA in court, the post says.

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