John Taylor’s exit from the agency comes as FDA Commissioner Margaret Hamburg awaits recommendations from a panel of senior agency officials on how to ensure the centers support Office of Regulatory Affairs’ activities without duplication.
With the departure in January of John Taylor, FDA Commissioner Margaret Hamburg will lose a top advisor who has filled important personnel gaps as she contemplates another reorganization of the agency.
Taylor will leave his post as counselor to the commissioner in the Office of the Commissioner. He has also been...
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Despite staffing cuts and uncertainty at the FDA, the US still offers EU medtech firms stronger regulatory support, regulatory expert Bassil Akra told Medtech Insight. This is especially valued as EU rules are often viewed as overly stringent, unclear and difficult to follow.
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EU4Health, the main funding instrument for EU health initiatives, has put renewed emphasis on orphan devices in its 2025 work program, published in July.
The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.
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.
Hopes that last-minute negotiations might exempt Brazil’s $300m medtech exports from the latest round of US tariffs have been dashed, leaving the industry braced for further market instability that countermeasures could trigger.
