Devices

Too Few High-Risk CV Device Post-Approval Studies

University of California San Francisco researchers say that since the implementation of the 21^st Century Cures Act, which directed FDA to consider the role of post-market information in determining the least burdensome means for approval, there has been no significant increase in the frequency of FDA post-approval study mandates for the highest risk cardiovascular devices, despite increased reliance on such data for some devices. Writing in JAMA Internal Medicine (subscription or purchase required), the researchers say post-approval studies were limited by delays, revisions, and terminations; lack of active control groups; and an emphasis on surrogate rather than clinical outcomes.

“To improve the timeliness, quality, and availability of post-marketing evidence,” the authors conclude, “FDA should consider requiring post-market randomized clinical trials that use clinical endpoints. FDA should also consider implementing time-limited device approvals, whereby continued marketing would be contingent on timely generation and reporting of clinically meaningful post-approval data.”

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

Read more

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