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Biotech

FDA Signs Off On Genetically Modified Salmon Without Labeling (consumerist.com) 514

kheldan writes: Today, in a historic decision, the FDA approved the marketing of genetically-engineered salmon for sale to the general public, without any sort of labeling to indicate to consumers they've been genetically altered. According to the article: "Though the Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the FDA the authority to require mandatory labeling of foods if there is a material difference between a GE product and its conventional counterpart, the agency says it is not requiring labeling of these GE fish 'Because the data and information evaluated show that AquAdvantage Salmon is not materially different from other Atlantic salmon.' In this case, the GE salmon use an rDNA construct composed of the growth hormone gene from Chinook salmon under the control of a promoter from another type of fish called an 'ocean pout.' According to the FDA, this tweak to the DNA allows the salmon to grow to market size faster than non-GE farm-raised salmon."
United States

FDA: We Can't Scale To Regulate Mobile Health Apps 123

chicksdaddy writes Mobile health and wellness is one of the fastest growing categories of mobile apps. Already, apps exist that measure your blood pressure and take your pulse, jobs traditionally done by tried and true instruments like blood pressure cuffs and stethoscopes. If that sounds to you like the kind of thing the FDA should be vetting, don't hold your breath. A senior advisor to the U.S. Food and Drug Administration (FDA) has warned that the current process for approving medical devices couldn't possibly meet the challenge of policing mobile health and wellness apps and that, in most cases, the agency won't even try. Bakul Patel, and advisor to the FDA, said the Agency couldn't scale to police hundreds of new health and wellness apps released each month to online marketplaces like the iTunes AppStore and Google Play.
Science

How Sequestration Will Affect Federal Research Agencies 277

carmendrahl writes "Unless Congress and the White House act before March 1, the automatic across-the-board spending cuts known as the sequester will kick in. And federal agencies are bracing for the fiscal impact. Federal agencies and the White House are releasing details about how these cuts will affect their operations. If the cuts take effect, expect fewer inspections to the food supply, cuts to programs that support cleanups at former nuclear plants, and plenty of researcher layoffs, among other things."
Biotech

FDA Wins Right To Regulate Adult Stem-Cell Treatments 216

ananyo writes "A court decision on 23 July could help to tame the largely unregulated field of adult stem-cell treatments. The US District Court in Washington DC affirmed the right of the Food and Drug Administration (FDA) to regulate therapies made from a patient's own processed stem cells. The case hinged on whether the court agreed with the FDA that such stem cells are drugs. The judge concurred, upholding an injunction brought by the FDA against Regenerative Sciences, based in Broomfield, Colorado. The FDA had ordered Regenerative Sciences to stop offering 'Regenexx', its stem cell treatment for joint pain, in August 2010. As Slashdot has noted before, they are far from the only company offering unproven stem cell therapies."
Government

FDA Cracking Down On X-ray Exposure For Kids 138

ericjones12398 writes "The Food and Drug Administration is proposing that manufacturers of X-ray machines and CT scanners do more to protect children from radiation exposure. If companies don't take steps to limit X-ray doses, the agency may require a label on their new equipment recommending it not be used on children. X-rays and CT scans can provide doctors with lots of useful information. But the radiation that creates the helpful images also increases a person's risk for cancer. There's been an explosion in the use of imaging tests. And rising radiation doses, particularly from CT scans, have drawn concern. The cancer risk increases with the dose of X-rays received during a person's lifetime, so kids' exposure is particularly important. It's also the case that children are more sensitive to X-ray damage. The FDA is also telling parents to speak up. If a doctor orders a test or procedure that uses X-rays, parents shouldn't be afraid to ask if it's really necessary. Also, it doesn't hurt to ask if there's an acceptable alternative, such as ultrasound or MRI, that doesn't rely on X-rays."
Government

FDA Backtracks On Antibiotic-Resistant Bacteria Proposal 172

NewYorkCountryLawyer writes "The FDA recognized, 35 years ago, that feeding animals low-doses of certain antibiotics used in human medicine — namely, penicillin and tetracyclines — could promote antibiotic-resistant bacteria capable of infecting people who eat meat, and proposed to withdraw approval for the use of those antibiotics in animal feed. Instead of acting upon the proposal, the FDA has now withdrawn it. Although admitting that it continues to have 'concerns' about the safety of the use of antibiotics in animal feed, the FDA says that it will just continue to rely on 'voluntary self-policing' by the industry, the same method which hasn't worked out too well during the past 35 years, as antibiotic use in livestock and antibiotic resistance have continued to rise throughout the entire period."

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