Devices

Warren, Murray Want More Device Approval Answers

Sens. Elizabeth Warren (D-MA) and Patty Murray (D-WA) say they were “disappointed” to learn that FDA no longer fully stands by a commitment made by former commissioner Scott Gottlieb to not use a conditional approval pathway for human medical products. In an 11/4 letter to FDA acting commissioner Brett Giroir and CDRH director Jeffrey Shuren, the senators reference an agency 8/21 response to their 6/24 letter on an agency legislative proposal to create a “progressive approval” pathway for human medical devices.

“We recognize the challenges in developing medical and surgical devices for populations with unmet medical needs,” Warren and Murray write. “However, we continue to have questions regarding the eligibility criteria FDA envisions for this proposal, FDA’s ability to ensure the quality and completeness of postmarket data collection; and the agency’s ability to exercise its authority to remove medical products from the market after they have been provisionally approved.”

The senators ask for answers to seven questions on the operation of a progressive approval pathway.

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