Devices

AdvaMed Code of Ethics Revisions

Three K&L Gates attorneys say revisions to the AdvaMed Code of Ethics on medical device company interactions with healthcare professionals, scheduled to take effect 1/1/20, provide “helpful clarifications and additional detail about how best to structure arrangements between companies and healthcare professionals.” They recommend that companies and healthcare professionals carefully review the code and assess whether any operational changes or contractual arrangements are required before the 2020 implementation.

Topics covered in the attorneys’ report include: consulting arrangements with healthcare professionals, company representatives providing technical support in clinical settings; communicating for the safe and effective use of medical technology; jointly conducted education and marketing programs; company-conducted programs and meetings with healthcare professionals; educational and research grants, charitable donations, and commercial sponsorships; provision of health economics and reimbursement information; and demonstration, evaluation, and consigned products.

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