Food And Drug Administration U S

In carrying out its mission to ensure that generic drugs are "the same medicine" with "the same results" as the pioneer drugs they follow, the Food and Drug Administration rigidly applies a standard of what is called "bioequivalence." Measured in laboratories and in simple, small-scale human trials, a generic must deliver the same active ingredient to the bloodstream of patients in virtually the same amount at virtually the same rate as the pioneer drug.

U.S. health regulators plan to review whether a popular type of laser eye surgery is improving patients' lives, a senior Food and Drug Administration official said. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said this week that a number of concerns had been raised about patient satisfaction with the vision correction procedure, known as laser-assisted in situ keratomileusis, or Lasik. An agency advisory panel will hold a public meeting to discuss the issue, Schultz said.

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.

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.

Tomatoes disappeared from cheeseburgers. Fresh salsa was suddenly in short supply. Supermarket produce sections were in disarray. Homemakers checked the fridge, and waiters were pressed to explain why certain menu items were simply unavailable. Amid concerns over a widening salmonella outbreak, the nation's restaurants, supermarkets and consumers faced a bleak tomato landscape Monday.

Federal officials said Thursday that they might never learn which farms produced tainted tomatoes that have now sickened 228 people in 23 states with a rare form of salmonella. "At this stage of the investigation there is no guarantee that we will be able to trace the outbreak back to the farm level, although that is the goal," David Acheson, the Food and Drug Administration's associate commissioner for foods, told reporters Thursday.

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.

The government bungled the salmonella outbreak probe so badly, a House committee chairman said Thursday, that federal investigators reminded him of the Keystone Kops. A committee member hoped the maligned tomato can get its good name back. The House Energy and Commerce Committee conducted its own investigation of the Food and Drug Administration's probe of the salmonella scare.

If we've learned anything watching our 401(k)s go down the toilet and the stock market take a pistol-whipping, it's that too-lax regulation and the nowhere-to-hide nature of the global economy leave us vulnerable to all sorts of shenanigans. Need more proof? Three words: China. Food. Melamine. On Tuesday, the Chinese government ordered all liquid and powdered milk manufactured before Sept. 14 to be removed from store shelves for testing.

The Food and Drug Administration's conclusion that a controversial chemical is safe for use in food containers is badly flawed, an independent panel of scientific advisors said in a report released Tuesday. The chemical, known as bisphenol A, is used to make plastic for food packaging, baby bottles and other consumer and medical goods. Environmental groups want to ban BPA in products for infants because of concerns that it can interfere with their development.