Devices

Harvard Analysis Backs Bills for New Device Regulatory Scheme

A new Harvard analysis lends support to recent bills introduced in the House and Senate that propose shorter “pre-market” clinical testing and better “post-market” surveillance than current standards for certain devices. The analysis is limited to coronary stents, and the researchers note their theoretical model “provides guidance on how to consider extrapolating to policy in other cases, doing so should be done with care.”

The researchers find that “if post-approval learning rates approach those we observe from clinical trials at a comparable cost, the benefits from such a policy change are substantial. In the extreme case where post-approval learning is fully informative and not too costly, the optimal policy is to require no pre-approval trials at all...”

The researchers find merit “to the argument that requiring shorter trials with enhanced post-approval testing could improve consumer welfare, but the gains from this policy critically depend on the rate and cost of learning via post-market surveillance,” according to the analysis. “For some products, observational learning from real world use may make it difficult to infer product quality (i.e., not having the randomization built into treatment and the control available in clinical trials). For other products, though—and likely for those in our sample—the problem is simply a lack of systematic data collection and sharing of information.”

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