Devices

Device User Fee Proposal Seeks $329 million to Cover New Initiatives

The latest medical device user fee proposal from FDA would cost $329 million more than the current user fee program, according to just-released user fee negotiation meeting minutes. FDA said the proposal addresses key innovation initiatives that are important to patient and consumer groups, such as patient input, real world evidence, and digital health.

On real world evidence, FDA’s proposal has a goal to “establish a collaboration that leverages data from routine clinical care that exists in registries, medical claims, electronic health records, and potentially other sources,” according to the minutes. “FDA shared that real world evidence has been leveraged for both premarket and postmarket regulatory decisions in areas such as post-approval studies, continued access studies, labeling extension studies, and postmarket surveillance studies,” the minutes continue. “FDA stated that to help develop the necessary infrastructure for a national evaluation system, FDA has been working with a planning board to help develop the organizational structure and governance model of the national evaluation system’s coordinating center, a financial plan for sustainability, and an implementation plan. FDA stated that the selection and operation of a coordinating center for a national evaluation system depends on securing funding, either from Congressional budget authority appropriations, private-sector funds, or a combination of both.”

The user fee proposal on real world evidence includes 15 staff that will develop and implement the framework for using such data for premarket decision-making by supporting the work of the coordinating center, as well as reviewing and analyzing the data submitted to support a premarket decision. The proposal also includes $10 million per year, all of which would support a coordinating center and projects to improve real world evidence data sources and increase their use. “FDA emphasized that the user fee investment will yield better quality registries so the data can be used in premarket regulatory decision-making and will provide the opportunity to nest clinical trials in registries, which is one way to reduce the cost of evidence generation,” the minutes say.

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