Devices

Industry Cuts FDA Ideas Out of MDUFA 4 Proposal

At a 2/18 FDA/Industry MDUFA 4 reauthorization meeting, AdvaMed, MDMA (the Medical Device Manufacturers Association, and MITA (the Medical Imaging and Technology Alliance) presented an updated proposal package including continuation of MDUFA 3 base resources to maintain the MDUFA 3 FTE levels and maintain FDA’s current performance, and proposals to invest in IT upgrades, continue the independent assessment, support patient engagement, and develop a quality management system. Meeting minutes indicate that FDA staff asked clarifying questions about that proposal and also about industry’s concerns with some elements of the agency’s 1/27 proposal.

The industry proposal included a two-tiered listing of topics for continued consideration and discussion and request to exclude consideration of review summaries for 510(k) sponsors and 513(g) performance goals.

FDA raised concern that many elements in its 1/27 package were not included in the industry proposal and some that of the areas were important to the agency.

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