New food safety rules aim for more accountability

A view shows the U.S. Food and Drug Administration (FDA) logo at its headquarters in Silver Spring(Reuters) – U.S. regulators proposed new food safety rules on Friday that aim to make food processors and farms more accountable for reducing foodborne illnesses that kill or sicken thousands of Americans annually. The new rules, required by the Food Safety Modernization Act (FSMA) that was signed into law two years ago, were announced by the U.S. Food and Drug Administration on Friday. "These proposed regulations are a sign of progress," said Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest, who has been a critic of the FDA. …

Chelsea’s hypotension drug fails to prove efficacy past week one

(Reuters) – Chelsea Therapeutics Inc said its experimental hypotension drug met the main goal of a study by significantly reducing dizziness in patients at week one, but results beyond that period were not statistically significant. The U.S. Food and Drug Administration declined to approve the drug, Northera, in March, and asked for data that proved it was effective over two to three months. The company’s shares, which have lost about two-thirds of its value so far this year, fell 22 percent to $1.40 in extended trading after closing at $1.79 on Tuesday on the Nasdaq. …

FDA, medical device industry form research partnership

(Reuters) – The Food and Drug Administration said it has formed a partnership with the medical device industry aimed at speeding the development and review of new device products. The nonprofit organization, called the Medical Device Innovation Consortium, will collaborate with patient support groups, academia, foundations and the Centers for Medicare and Medicaid Services to improve the process for bringing medical devices into the marketplace. …

FDA seeks end of lawsuit over delayed food safety rules

The headquarters of the U.S. Food and Drug Administration is shown in Silver Spring near Washington(Reuters) – Creating new rules for food safety is too complex a task to be completed quickly and a lawsuit seeking to compel government action should be dismissed, according to the U.S. Food and Drug Administration. The FDA said that although it was behind schedule in modernizing food safety regulations as set out in a law signed in January 2011, the agency's broad role in regulating a $450 billion domestic and imported food business requires additional time. "The enormity and scope of the task given to FDA cannot be overstated," the FDA said in a motion filed Friday in U.S. …

New Cases, Death Rate Slows in Fungal Meningitis Outbreak

New Cases, Death Rate Slows in Fungal Meningitis OutbreakIf there's any positive news to be known about the fungal meningitis outbreak, linked to tainted injectable medications manufactured by the New England Compounding Center, NECC, is that at long last the reports of new infections and deaths having occurred are coming in more slowly. A consumer watchdog group, Public Citizen, has written a letter to the U.S. Food and Drug Administration asking it to revisit 16 compounding pharmacies to which the agency had issued warnings from 2003 through 2012, in an effort to prevent any such health tragedies in the future.

FDA approves Exelixis’ cabozantinib for thyroid cancer

WASHINGTON (Reuters) – The U.S. Food and Drug Administration on Thursday approved Exelixis Inc’s cabozantinib as a treatment for medullary thyroid cancer that has spread to other parts of the body. Cabozantinib, the company’s lead product candidate, is an oral drug designed to limit blood supply to tumors as well as block two segments of a pathway used by cancer cells to grow and spread. The FDA announcement came shortly after the close of stock market trading in New York, where Exelixis shares eased slightly on the day at $5.24 per share. …

Ranbaxy halts generic Lipitor production after recall: FDA

(Reuters) – Indian generic drugmaker Ranbaxy Laboratories will stop manufacturing its version of Pfizer Inc’s cholesterol fighter, Lipitor, while it gets to the bottom of the cause of a recent recall, the U.S. Food and Drug Administration said on its website. Earlier this month, Ranbaxy recalled certain lots of the widely used cholesterol lowering medicine known generically as atorvastatin at doses of 10 milligrams, 20 mg and 40 mg after the company discovered contamination with tiny glass particles. …

FDA advisory panel backs J&J tuberculosis drug

(Reuters) – An advisory panel to the U.S. Food and Drug Administration on Wednesday voted that an experimental Johnson & Johnson drug for multidrug-resistant tuberculosis appears to be safe and effective, but highlighted potential heart and liver-safety issues. The medicine, called bedaquiline, targets adenosine triphosphate synthase, an enzyme the tuberculosis bacterium needs to generate its energy. If approved, J&J said it would be the first drug in 40 years with a new mechanism of action against tuberculosis. …

FDA suspends peanut butter plant linked to salmonella outbreak

(Reuters) – The U.S. Food and Drug Administration suspended operations on Monday at a New Mexico food producer linked to salmonella-tainted peanut butter that has sickened at least 41 people this year, the agency said in a statement. The FDA said it had suspended Sunland Inc’s food facility registration “in the interest of public health,” following the national outbreak and a history of food safety violations reaching back over three years. “The fact that peanut butter made by the company has been linked to an outbreak … …

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