June 21, 2008 |
Several farms in Florida and Mexico appear to have produced at least some of the tomatoes implicated in what is shaping up to be the country's largest tomato-borne salmonella outbreak, federal health officials said Friday. But the lengthy search for the source of the bacteria continues, said David Acheson, the Food and Drug Administration's associate commissioner for foods, in a conference call with reporters.
April 3, 2008 |
Landmark legislation that would give the federal government the power to regulate cigarettes and other tobacco products passed an early hurdle Wednesday. The House Energy and Commerce Committee approved the bill, 38 to 12. The measure would allow the Food and Drug Administration to review new tobacco products before they go on sale, limit advertising and restrict sales to youths. It also would enable the agency to regulate levels of tar, nicotine and other ingredients.
March 29, 2008 |
The Food and Drug Administration said Friday that it wanted to fine Advanced Bionics, a Sylmar-based maker of cochlear implant hearing aids, $2.2 million for alleged manufacturing violations that put patients at risk. The FDA accused Advanced Bionics of failing to follow manufacturing standards to ensure the safety and quality of the hearing aids.
March 14, 2008 |
In mixed news for biotech giant Amgen Inc., a Food and Drug Administration panel recommended Thursday that doctors continue to prescribe the company's lucrative anemia drugs for patients with cancer. But the panel suggested scaling back which patients should be treated based on their type of cancer and the severity of the disease. The recommendations could lead to further sales declines in the company's blockbuster drug Aranesp. Thousand Oaks-based Amgen makes an identical product that is sold under the name Procrit by Johnson & Johnson.
March 3, 2008 |
Botox is known for smoothing furrowed brows. Now it's causing a few. The Food and Drug Administration last month issued a statement that Botox and another botulinum toxin drug, Myobloc, have been linked to serious respiratory and swallowing problems and at least one death. And consumers seeking to smooth their facial lines want to know: Is it safe? The primary fact to keep in mind, doctors say, is that Botox -- the only botulinum toxin drug approved in the U.S.
February 19, 2008 |
U.S. health officials evaluated the wrong factory when assessing the safety of a Chinese-made drug ingredient that may be a source of problems with a blood thinner, the Food and Drug Administration said Monday. Baxter International Inc.'s heparin has been linked to four deaths and hundreds of reports of allergic reactions. An investigation will take FDA inspectors to China this week.