In an interview with Medtech Insight, Amy Abernethy, the US FDA’s outgoing second-in-command, threw her weight behind Janet Woodcock to be the agency’s next commissioner. News of Abernethy’s impending departure from the FDA and other stories topped our list of most-read Medtech Insight articles in March.
Janet Woodcock is the “right person” for the role of US Food and Drug Administration commissioner, the agency’s outgoing No. 2 official told Medtech Insight on 1 April.
“I feel very strongly about Janet Woodcock being the right person. I felt comfortable leaving my role because of the...
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The FDA's Device Clinical Trial Snapshot Pilot, aimed at increasing trial transparency and diversity, has been canceled following President Trump’s anti-DEI executive order. Critics warn this may hinder trial transparency, impacting public health and demographic data accessibility.
The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.
Medical device firms often have serious compliance gaps, a recent Veeva MedTech survey found. Only 50% of the companies surveyed are confident in their global registration data, with 70% reporting inconsistencies during audits. The report recommends automation and better data governance.
The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.
The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.
The FTC is suing to block Edwards Lifesciences' purchase of JenaValve, citing concerns that it would reduce competition and innovation in the heart valve market and negatively impact patient access to vital treatments for aortic regurgitation. Edwards disagrees with the decision.
The US FDA issued a pair of early alerts on Wednesday warning customers about serious adverse events associated with two Boston Scientific cardiac devices. Both alerts include numerous reports of injuries and deaths and are part of the FDA’s ongoing pilot to enhance its recall process.
