President Trump signed off on legislation allowing US FDA to authorize additional emergency uses for medical products to reduce deaths and impacts of injuries caused by "agents of war." The signature ends a turf battle between FDA and the Department of Defense over authorizing products needed quickly under the emergency conditions of war.
A bill signed by President Trump on Nov. 12 – the same day he approved a conference report on the National Defense Authorization Act (NDAA) – clarifies that FDA has the authority to authorize additional emergency uses by the US military for medical products used during war time, or as agents of war.
H.R. 4374 calls on the Secretary of Defense to request a fast-track review from FDA of any medical...
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At an Aug. 4 public meeting on MDUFA VI, FDA officials, industry representatives, and patient advocates outlined their priorities for the next user fee agreement, highlighting goals such as improved transparency, streamlined reviews, enhanced safety measures, and greater patient involvement.
Pending legislation seeks to address what the sponsors argue is a lack of transparency in medical billing. If enacted, the bill would provide patients with the costs of procedures and medications before receiving them. A data collection expert discusses what the bill could mean for patients.
NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.
The US House of Representatives passes legislation requiring manufacturers of non-flushable wet wipes to label products as ‘non-flushable," a move endorsed by the Personal Care Products Council.
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.
In return for building a successful US export business, Switzerland has been handed a 39% tariff effective immediately by the Trump administration. Diplomatic channels have been reopened to undo the tariff. Meanwhile, the medtech industry is looking to develop OUS markets for Swiss exporters.
