Devices

FDA Reports Progress in MDUFA 6 Negotiations

Minutes from the 1/21 MDUFA 6 reauthorization meeting indicate progress is being made in several areas. The minutes say industry representatives gave their feedback on real-world evidence (RWE), saying they support the National Evaluation System for Health Technology (NEST) and emphasizing that NEST Mark is potentially an important future tool for evaluating RWE quality. Industry said collaboration appears to be going well and requested more specifics on FDA’s proposed RWE investment regarding the full-time equivalents and operational dollars to understand how the funds will be spent, explain more detail on data sources that would be leveraged and how they translate to premarket review, and what current FTEs are doing in RWE at this time. FDA said it will work to provide the requested information.

Areas of agreement and areas needing more discussion involving de novo and the presubmission programs were discussed.

There was agreement on a set of 510(k) total time to decision goals and on a way to move forward on the agency’s international harmonization proposal.

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