Sen. Chuck Grassley, R-Iowa, April 10 pressed HHS Secretary Sebelius to be certain that financial data reported by device and drug companies to the forthcoming Open Payments database tied to the value of medical journal article reprints be put into context.
Sen. Chuck Grassley, R-Iowa, pressed HHS Secretary Kathleen Sebelius at an April 10 Senate hearing that providers want drug and device manufacturers to be able to “put into context” data on the value of medical journal articles reprints they give to physicians, before that information comes out in the publicly accessible Open Payments database that CMS will release this fall.
“I want you to say … that providers will have a chance to put that spending information into context,” Grassley...
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.
A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.
US Medicare has proposed national coverage of renal denervation for patients with uncontrolled hypertension. The treatment is seeing other advances as well, with Medtronic piloting a longer catheter and a multi-organ approach and a blood test to identify the best candidates fresh on the
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.
