The number of internal scientific disagreements over device approvals has waned since late 2009, when the FDA implemented new procedures for handling such disputes, but many employees are still hesitant…
The House Appropriations Committee subcommittee that oversees FDA funding recommends fiscal 2013 appropriations that would slightly reduce agency spending. A full committee markup of the bill, as yet unnumbered, hasn’t…
The FDA has cited a manufacturer of cranial remodeling helmets on seven areas of documentation and policy flaws.
Johnson & Johnson’s (J&J) Ethicon unit will halt sales of some vaginal mesh products implicated in a class action lawsuit, but says it needs time to conduct the withdrawal properly.
Opponents of the medical device excise tax, mandated in the 2010 Affordable Care Act, are one step closer to repealing the contentious measure, after the House voted 270-146 to pass…