The FDA has decided that the death last month of a patient taking Biogen Idec's hot multiple sclerosis pill Tecfidera was important enough to mention on Tecfidera labels.
The battle is heating up over the FDA's draft guidance on the oversight of lab-developed tests, says the FDA Law Blog, which detailed both sides' actions over the last couple of weeks.
When Biogen Idec reported last month that a patient taking its hot multiple sclerosis pill Tecfidera had developed a rare brain infection and died, the drugmaker said it believed the safety profile of the drug remained solid. Perhaps so, but the FDA has decided the death was important enough to add a description of it on Tecfidera labels.
A bill circulating the halls of Congress would limit the FDA's oversight of electronic health records and clinical decision support software, but may not have much practical effect since the agency limited its role in the regulation of software in a June draft guidance.
Covidien today announced FDA 510(k) clearance for its Fortrex percutaneous transluminal angioplasty balloon catheter, designed to maintain arteriovenous access in hemodialysis patients suffering from chronic kidney disease or end-stage renal failure.
Amid growing backlash over tools used in minimally invasive gynecological procedures, the FDA is cracking down on the devices in updated safety guidance.
The FDA originally proposed requiring implantable medical devices to bear a unique device identification code on their surface. But industry protested that part of the proposed rule, so the agency ultimately opted to rely on packaging as the surface for UDIs. However, some orthopedics are removed from their packaging well before surgery or implantation, forcing the FDA to make a change on the fly.
A U.S. oncologist who thought he was getting a great deal on drugs that were almost the same thing as Avastin has found they will cost him an extra $2 million and a federal misdemeanor conviction.
The market price of a priority review voucher at the FDA just doubled. Canada's Knight Therapeutics has auctioned off its voucher--which can be turned in to the FDA in exchange for a regulatory shortcut on a drug decision--for $125 million to Gilead, one of the most aggressive developers in the industry.
The FDA is extending its tentacles deeper into China, which exported medical devices worth $3.5 billion to the U.S. in 2012, according to the U.S. Department of Commerce.