Devices

FDA Likely to Miss Review Deadlines: Staff

Several FDA scientists who still have positions at the agency have told Reuters anonymously that the agency is likely to miss congressionally mandated user fee review deadlines for medical devices. The news service’s exclusive report says the scientists have been told to shelve easier applications and stop providing early feedback on planned applications in favor of working on more complex reviews that take more time.

In a first round of cuts reportedly mandated by the so-called Department of Government Efficiency, FDA lost about 1,000 probationary employees, although some were later recalled. Reuters says it was unable to determine the total number of first-round dismissals. FDA is expected to lose about 3,500 people under a 3/27 HHS announcement that it will cut some 10,000 positions across its agencies, the news service says.

The article quotes attorney Eva Temkin (Arnold & Porter), who has clients submitting drug and medical device applications, as saying that even if reviewers are not dismissed in the second round, other staff such as policy experts and attorneys are crucial for the timely review of applications. “If this plan goes forward, I do expect to see missed user fee goals and commitments,” she said.

Another attorney who spoke anonymously to Reuters said that her medical device company clients were deeply concerned that the agency would start missing deadlines following the earlier layoffs. The trade group AdvaMed said it has been hearing similar concerns from its members.

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