Devices

3 Companies Like AdvaMed Comments on Draft Guidance

Zimmer Biomet, Stryker, and Johnson & Johnson all say they agree with comments submitted by AdvaMed on an FDA draft guidance on characterization of ultrahigh molecular weight polyethylene (UHMWPE) used in orthopedic devices. Stryker says that as in the AdvaMed comments, it also recommends that the agency finalize the guidance as soon as possible and revise it to reference two ASTM standards.

Zimmer Biomet also calls for referencing the two ASTM standards and says that FDA should ensure that its draft guidance and the two standards, which were recently recognized by the agency, are aligned and consistent.

In addition to associating itself with the AdvaMed comments, Johnson & Johnson says that it is important to focus on these key issues: clarifying the definition of conventional UHMWPE, correcting references to antioxidant containing UHMWPE, clarifying the types of polyethylene used in implants, correcting the reference to annealing, correcting the discussion of shelf life and stability, and clarifying that ASTM F648 applies only to conventional UHMWPE.

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