Showing posts with label seeks. Show all posts
Showing posts with label seeks. Show all posts

Tuesday, July 31, 2012

23andMe seeks FDA approval for personal DNA test

Genetic test maker 23andMe is asking the Food and Drug Administration to approve its personalized DNA test in a move that, if successful, could boost acceptance of technology that is viewed skeptically by leading scientists who question its usefulness.

23andMe is part of a fledgling industry that allows consumers to peek into their genetic code for details about their ancestry and future health. The company's saliva-based kits have attracted scrutiny for claiming to help users detect whether they are likely to develop illnesses like breast cancer, heart disease and Alzheimer's.

The biology of how DNA variations actually lead to certain diseases is still poorly understood, and many geneticists say such tests are built on flimsy evidence.

For years, the Silicon Valley company has resisted government regulation, arguing that it simply provides consumers with information, not a medical service. But now company executives say they are seeking government approval

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Wednesday, April 11, 2012

FDA Seeks to Limit Antibiotics in Animal Feed

HealthDay – 57 mins ago WEDNESDAY, April 11 (HealthDay News) -- The U.S. Food and Drug Administration unveiled Wednesday a plan to reduce the use of antibiotics in animal feed.

The practice of mixing antibiotics in animal feed to make livestock, pigs and chickens gain weight and become more resistant to disease has been criticized in many quarters. Health experts contend that this overuse of antibiotics has led to an increase of germs that are growing increasingly resistant to antibiotics, threatening human health.

The FDA said it was issuing three documents to help veterinarians, farmers and animal producers use medically important antibiotics "judiciously" by limiting their use only to combat diseases and other health problems. Under this "voluntary" initiative, certain antibiotics would not be used for so-called "production" purposes, which include enhancing growth or improving the effectiveness of animal feed, the agency said in a news release.

These antibiotics would still be available to prevent, control or treat illnesses in food-producing animals under the supervision of a veterinarian, the agency said.

"It is critical that we take action to protect public health," FDA Commissioner Dr. Margaret Hamburg, said in the news release. "The new strategy will ensure farmers and veterinarians can care for animals while ensuring the medicines people need remain safe and effective. We are also reaching out to animal producers who operate on a smaller scale or in remote locations to help ensure the drugs they need to protect the health of their animals are still available."

The FDA said it was publishing three documents Wednesday in the Federal Register detailing its efforts to limit antibiotic use in animal feed:

A final guidance for industry, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, that recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs. A draft guidance, open for public comment, which will assist drug companies in voluntarily removing production uses of antibiotics from their FDA-approved product labels; adding, where appropriate, scientifically supported disease prevention, control, and treatment uses; and changing the marketing status to include veterinary oversight.A draft proposed Veterinary Feed Directive regulation, open for public comment, that outlines ways that veterinarians can authorize the use of certain animal drugs in feed, which is important to make the needed veterinary oversight feasible and efficient.

Dr. John Clifford, chief veterinary medical officer for the U.S. Department of Agriculture, said in the news release: "USDA worked with the FDA to ensure that the voices of livestock producers across the country were taken into account, and we will continue to collaborate with the FDA, the American Veterinary Medical Association and livestock groups to ensure that the appropriate services are available to help make this transition."

Public health advocates are skeptical about asking drug makers to voluntarily restrict use of their products, the Associated Press reported.

"This is not an issue where trust should be the measure. This is an issue where the measure is whether or not the FDA has fulfilled its authority of protecting public health," Richard Wood, Chair of the Keep Antibiotics Working coalition, said in a statement, the AP reported.



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Regulators seeks voluntary antibiotic limits in livestock

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Sunday, April 8, 2012

Isn't it "marvelous?" Obama seeks to define Romney for voters

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