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.
Many clinical trials rely on patient-reported outcomes to determine whether drugs are working, but with disparate methods employed across the industry, it can be difficult to compare the results from one study with those of another. With that in mind, the FDA has recruited CRO giant Icon to help develop an industry standard for patient polling in antibacterial R&D.
The doctor who brought the cancer risks posed by power morcellation to the attention of the public and the FDA protested what he described as "imminent plans to use legal mechanisms to functionally institute a 'registry of outcomes' or a 'probationary period' in order to avoid banning power morcellators from the marketplace," in an email to Commissioner Hamburg, various U.S. senators, White House officials and others obtained by FierceMedicalDevices.
The FDA resumed its active search for a CIO late last month, more than one year after it first advertised the position, Regulatory Focus reports.