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…
Weighing the risks and benefits of Intercept Pharmaceuticals’ obeticholic acid, an FDA advisory committee voted unanimously 17-0 on the significance of alkaline phosphatase levels as evidence to justify an accelerated…
View the entire issue. Source: Drug Industry Daily
With the completion of the Senate HELP Committee’s third and final markup on biomedical innovation legislation, a complete cures package is expected to hit the full Senate shortly. Source: Drug…
The FDA has taken two clinical investigators to task for deviating from their investigational plans. Source: Drug Industry Daily
Gaping GMP holes in Swedish contract manufacturer Apotek Produktion & Laboratorier’s processes resulted in a seven-item Form 483 following an Oct. 5 to 9, 2015 inspection. Source: Drug Industry Daily