As of last month, FDA and industry were several hundred million dollars apart, according to recently released negotiation meeting minutes. And insiders suggest the two are still haggling over the total amount companies will need to shell out in the five-year user fee reauthorization.
FDA and device industry negotiators have zeroed in on what program improvements they’d like to see in the 2012 user fee pact, but a significant gap remains on how much the two parties believe industry should pay in the final agreement.
As of last month, they were several hundred million dollars apart, according to recently released negotiation meeting minutes
The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.
In recognition of Mental Health Awareness month, Sarah Jenkins, executive director at the National Association for Continence, discussed the mental health issues that often come with incontinence.
The FDA plans to implement artificial intelligence in its scientific review process by 30 June, following a successful pilot. The agency hopes the tool will reduce nonproductive tasks for reviewers amid recent staff cuts. A Chief AI Officer will oversee the rollout and integration.
