The FDA is looking for a faster test to detect the presence of salmonella. Lab tests take as long as nine days to deliver results, and outbreaks can take weeks to identify, said one food safety expert.
The FDA has approved SyntheMed's Repel-CV, a device designed to minimize the formation of adhesions, or bands of scar tissue, in children who undergo open-heart surgery. Cardiac adhesions can impede the heart's function by binding the organ's outer membrane to surrounding tissues, the agency said.
Momenta Pharmaceuticals might get FDA clearance this year to launch its version of Lovenox, a blood thinner by Sanofi-Aventis, before President Barack Obama's proposal that would allow biogenerics is enacted. The Massachusetts biotech firm is in a "unique position" to conquer the market for generic biotech medicines, given its advanced drug technology -- developed by the Massachusetts Institute of Technology -- and good relationship with the FDA, an analyst said.
The FDA is conducting a survey to determine data sources that could participate in the Sentinel Initiative. The project calls for a national electronic system that would allow the agency to search existing databases for safety information on medical products approved by the FDA.
An FDA panel is scheduled March 31 to review Genentech's application to promote Avastin as a treatment for a deadly form of brain cancer called glioblastoma multiforme. Avastin, which is approved to treat colon, breast and lung cancers, generated $2.69 billion in U.S. sales last year.
The FDA has granted marketing approval to Sicel Technologies for an implantable sensor designed to measure radiation doses being administered to patients with breast and prostate cancers. The company plans to test the device in lung cancer and is seeking CE Mark approval from the European Union, CEO Mike Riddle said.