The agency is still working to get an oncology center of excellence off the ground and has other large pending reorganizations to tackle before it may get to creating additional centers intended to break down device, drug and biologic silos.
US FDA may wind up only meeting the minimum requirements for establishing inter-center institutes within the agency that are included in the new version of the 21st Century Cures bill.
The legislation, which was approved by the House Nov. 30 and is expected to be approved by the...
Create an account to read this article
Already a subscriber?
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.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.
The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.
Steve Bates, head of the UK BioIndustry Association, has been appointed executive chair of the government’s Office for Life Sciences as the UK restructures its life sciences approach and drives health outcomes with a new NHS Long-Term Care plan.
The UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.
