Leaders in Congress said they hope to pass a short-term, two-week 2018 "continuing resolution" by Dec. 8 to fund US FDA and other federal agencies until Dec. 22. Industry lobbyists also hope to squeeze device tax repeal language into a final budget measure this month, and medical researchers are asking Congress to lift the budget cap for more National Institutes of Health funding.
Republican Senate Majority Leader Mitch McConnell and House Speaker Paul Ryan vowed to prevent an FDA and government-wide shut down by passing a two-week continuing resolution before current funding runs out on Dec. 8.
Democrats in the House and Senate, including Senate Majority Leader Chuck Schumer and House Minority Leader Nancy Pelosi agreed. They...
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.
During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.
A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.
Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.
16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.
With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.
Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?
