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.
For nearly two years, efforts by the FDA to expand its oversight of Chinese pharmaceuticals manufactured for the U.S. market have been thwarted, an issue FDA Commissioner Margaret Hamburg hopes to resolve during a visit there this week to meet with Chinese and other global regulators.
While in China for the International Summit of Heads of Medicines Regulatory Agencies, FDA Commissioner Margaret Hamburg will meet with top Chinese regulatory officials about working cooperatively on drug and food safety.
FDA's Ophthalmic Devices Advisory Committee panel overwhelming recommended PMA approval of Alcon's ReSTOR Multifocal Toric Intraocular Lens for patients undergoing cataract eye surgery who are astigmatic and suffer from presbyopia.
Late on Friday the FDA put out the word that it has reversed its earlier decision against Sanofi's multiple sclerosis drug Lemtrada, agreeing to allow the pharma giant the right to market the treatment--with some tight controls on just who will get this drug for the relapsing form of the disease.
Exton, PA's West Pharmaceutical Services just announced that the FDA has given it 510(k) clearance for the NovaGuard Staked-needle Automatic safety system, as the push to avoid needlestick injuries gathers momentum.
In the 10 years since the FDA found that antidepressants carried an increased risk of suicidal thoughts and behaviors in teens and slapped a black box warning on the drugs, psychiatry experts remain divided on the warnings' efficacy, with some calling for a removal of the label altogether.