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Keyword: fda

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  • Valsartan recall: 4 things patients should know

    07/19/2018 8:15:14 AM PDT · by Red Badger · 17 replies
    CNN ^ | Updated 4:10 AM ET, Thu July 19, 2018 | By Jacqueline Howard
    Several common drugs that contain valsartan, used to treat high blood pressure and heart failure, were recalled in the United States on Friday due to an "impurity" in the drug that poses a potential cancer risk. That impurity, N-nitrosodimethylamine or NDMA, is classified as a probable human carcinogen, based on results from lab tests. The medicines included in the voluntary recall are valsartan from Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries, as well as valsartan/hydrochlorothiazide from Solco and Teva. Valsartan is off patent and is used as a component of other generic medicines, but not all medicines containing the...
  • FDA to explore importing drugs from overseas to lower prices

    07/19/2018 8:01:48 AM PDT · by GonzoII · 17 replies
    Washington Times ^ | July 19, 2018 | Robert King
    The Trump administration wants to explore how to safely import pharmaceuticals from other countries in order to counteract major hikes in the price of drugs. Such a policy would represent a major shift from current procedure. Health and Human Services Secretary Alex Azar requested on Thursday that the Food and Drug Administration establish a working group to examine safe importation. The request is part of a larger effort by the Trump administration to tackle high drug prices, a growing driver of healthcare costs in the U.S. “We have seen a number of both branded and generic examples in recent years...
  • FDA Recalls Common Heart Drug For Potential Cancer Risk

    07/18/2018 9:09:27 AM PDT · by sodpoodle · 34 replies
    CBS ^ | 7/16/2018 | Jen Christensen
    The recall of a common drug used to control blood pressure and help prevent heart failure was announced by the US Food and Drug Administration on Friday, a week after 22 other countries recalled it because the drug contains a chemical that poses a potential cancer risk. Valsartan is off patent and is used as a component of other generic medicines, but not all medicines containing the ingredient are involved, according to the FDA. The US recall includes the the versions of valsartan that are made by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd. as well as valsartan/hydrochlorothiazide...
  • The time is long overdue to abolish the FDA.

    07/14/2018 6:54:40 PM PDT · by ProgressingAmerica · 28 replies
    In the last several days I've had four different people in discussions about what is going on with cigar regulations. For whatever reason, this story has people talking. On the surface, that's great. The devastation that government regulation wreaks upon our society normally goes unnoticed. But my answer to solve the problem is one that nobody ever considers: Abolish the Food and Drug Administration. And I know what thoughts people have in their minds because I can see the look of surprise on their faces: "But what about our food?" "what about drug safety?" These and other questions just like...
  • FDA OKs 1st drug to treat smallpox, in case of terror attack

    07/13/2018 8:10:03 PM PDT · by Olog-hai · 10 replies
    Associated Press ^ | Jul. 13, 2018 7:08 PM EDT | Linda A. Johnson
    U.S. regulators Friday approved the first treatment for smallpox — a deadly disease that was wiped out four decades ago — in case the virus is used in a terror attack. Smallpox, which is highly contagious, was eradicated worldwide by 1980 after a huge vaccination campaign. But people born since then haven’t been vaccinated, and small samples of the smallpox virus were saved for research purposes, leaving the possibility it could be used as a biological weapon. Maker SIGA Technologies of New York has already delivered 2 million treatments that will be stockpiled by the government, which partially paid for...
  • 'If You Have a Cheese Pizza...': Mulvaney Amazes Trump With Explanation of 'Ridiculous' Gov't

    06/21/2018 3:35:02 PM PDT · by Hojczyk · 28 replies
    Fox News ^ | June 21,2018
    Office of Management & Budget Director Mick Mulvaney gave an intricate and often eccentric explanation of redundancy and overlap in federal bureaucracy in a presentation that stunned the president and the press. "I call this the 'drain the swamp' cabinet meeting," Mulvaney said, adding that it has been about 100 years since the federal government was reorganized at this scale. He criticized the "Byzantine nature" by which the government regulates, creating headaches for business owners, employees and taxpayers. "If you have a cheese pizza, it's governed by the Food & Drug Administration. If you put a pepperoni on it, it's...
  • Trump signs 'right-to-try,' allowing gravely ill patients to bypass FDA for experimental treatment

    05/30/2018 10:20:40 AM PDT · by SeekAndFind · 37 replies
    CNBC ^ | 05/30/2018
    President Donald Trump is slated to sign the controversial "right-to-try" bill on Wednesday, which would bypass drug regulators to give gravely ill patients access to experimental medicines. The legislation allows patients with life-threatening conditions to ask drugmakers for medicines that have cleared some testing but still haven't been approved by the Food and Drug Administration. Previously, people would need to ask the FDA for access to experimental treatments. Trump and Vice President Mike Pence had been major supporters of passing the measure, which supporters say gives patients hope they would not otherwise have. The House of Representatives approved the bill...
  • Marc Thiessen: Thank Republicans for your Right to Try

    05/30/2018 9:29:10 AM PDT · by jazusamo · 8 replies
    Fox News ^ | May 30, 2018 | Marc Thiessen
    WASHINGTON -- Imagine the horror of learning you have a terminal illness for which science has not yet come up with a treatment. Now imagine receiving the same diagnosis, and then learning a promising new treatment exists that could save your life -- but you can't get access to it thanks to governmental obstacles. That is the nightmare that befell Andrea Sloan, an Austin lobbyist who gave up her job at a high-priced law firm to advocate for victims of domestic violence. In 2007, Sloan was diagnosed with ovarian cancer, and for more than six years tried every Food and...
  • Maple, honey producers not sweet on added sugars label

    05/03/2018 7:13:43 AM PDT · by Michamilton · 63 replies
    Washington Post ^ | May 1, 2018 | Lisa Rathke
    EAST MONTPELIER – Producers of pure maple syrup and honey aren’t sweet on a plan to label their pure natural products as containing added sugars. The U.S. Food and Drug Administration will be requiring updated nutrition labels for products that are expected to say that pure maple syrup and honey contain added sugars, which the producers and officials say is misleading and confusing and could hurt their industries. "There are no added sugars. Maple is a pure product," said U.S. Rep. Peter Welch of Vermont, the top maple producing state in the country.
  • Weedkiller found in granola and crackers, internal FDA emails show

    04/30/2018 8:34:18 AM PDT · by Mariner · 73 replies
    The Guardian ^ | April 30th, 2018 | Carey Gillam
    US government scientists have detected a weedkiller linked to cancer in an array of commonly consumed foods, emails obtained through a freedom of information request show. The Food and Drug Administration (FDA) has been testing food samples for residues of glyphosate, the active ingredient in hundreds of widely used herbicide products, for two years, but has not yet released any official results. But the internal documents obtained by the Guardian show the FDA has had trouble finding any food that does not carry traces of the pesticide. “I have brought wheat crackers, granola cereal and corn meal from home and...
  • nearly three-quarters of medical scopes tainted by bacteria

    04/25/2018 6:23:51 PM PDT · by spintreebob · 19 replies
    Modern Healthcare ^ | 4-24-18 | Chad Terhune
    In an ominous sign for patient safety, 71% of reusable medical scopes deemed ready for use on patients tested positive for bacteria at three major U.S. hospitals, according to a new study. The paper, published recently in the American Journal of Infection Control, underscores the infection risk posed by a commonly used endoscopes. It signals a lack of progress by manufacturers, hospitals and regulators in reducing contamination despite numerous reports of superbug outbreaks and patient deaths, experts say. "These results are pretty scary," said Janet Haas, president of the Association for Professionals in Infection Control and Epidemiology. "These are very...
  • On pizza regulations, Trump slices differently than his own FDA commissioner

    04/24/2018 10:45:43 AM PDT · by Red Badger · 78 replies
    www.washingtonexaminer.com ^ | April 24, 2018 12:00 AM | by Jim Gerety
    Unlike other food establishments that have static menu options, pizza is highly variable: Domino’s offers consumers 34 million different combinations of pizza. (iStock Photo) _______________________________________________________________________________________________________ As the owner of 18 Domino’s stores in Texas, I do not cut corners, whether on pizzas or complying with the law. Unfortunately, on May 7 the law will become especially burdensome and unhelpful to my customers. That day, President Trump’s FDA Commissioner Scott Gottlieb will implement a nationwide, Obama-era menu-labeling rule requiring restaurants with 20 or more locations to post in-store menu boards listing the calories of every item sold. I fully support efforts...
  • The Science Is Settled: Carbs Are Causing Global Warming

    04/16/2018 7:51:43 AM PDT · by NOBO2012 · 40 replies
    MOTUS A.D. ^ | 4-16-18 | MOTUS
    Science writer Gary Taubes has a knack for subverting conventional wisdom. Sixteen years ago, he published a groundbreaking feature article in The New York Times Magazine arguing that decades' worth of government-approved nutritional advice was flat-out wrong, ideologically motivated, and contributing to rising rates of obesity and diabetes. Traditional dieting guidance attacking fatty food and praising carbohydrates, he wrote, was based on "a big fat lie." – The Man Who Hated Carbs Before It Was Cool Of course Dr. Atkins had been saying essentially the same thing for 30 years before Taubes wrote his article for the NYT. But...
  • FDA Bans Pure Bulk Caffeine Products, Citing "Significant Public Health Concern"

    04/15/2018 7:58:02 AM PDT · by BenLurkin · 51 replies
    newsweek ^ | Kate Sheridan
    Companies can no longer sell bulk packages of liquid or powdered caffeine directly to consumers, the Food and Drug Administration announced Friday. The policy will take immediate effect “given the significant public health concern,” according to the agency’s statement released Friday. “Highly concentrated and pure caffeine, often sold in bulk packages, have been linked to at least two deaths in otherwise healthy individuals,” the agency stated. ... Between 10 and 14 grams of caffeine is considered life-threatening, according to the FDA’s guidelines, though people can have an irregular or rapid heart rate and seizures after taking just a gram. The...
  • 207 million eggs in nine states recalled over salmonella fears

    04/14/2018 10:42:55 PM PDT · by blueplum · 56 replies
    CNN via MSN ^ | 14 Apr 2018 | Faith Karimi
    A farm in Indiana is recalling more than 200 million eggs sold in nine states over salmonella fears. Rose Acre Farms voluntarily recalled 206,749,248 eggs due to potential contamination with Salmonella Braenderup, the Food and Drug Administration said in a statement. At least 22 illnesses have been reported so far, the FDA said Friday. The eggs were sold through retail stores and restaurants. They reached consumers in ...
  • Dairy Farmer Sues FDA for the Right to Label His Skim Milk as “Skim Milk”

    04/12/2018 1:42:32 PM PDT · by Red Badger · 36 replies
    modernfarmer.com ^ | April 10, 2018 | By Dan Nosowitz
    If we had an actual, physical folder of evidence that the food labeling system in the United States is broken, it'd be full to bursting. And we'd be adding "skim milk????" to the list right about now. Maryland dairy farmers Randy and Karen Sowers are, with the help of the Institute for Justice (a non-profit libertarian-leaning law firm), suing the Food and Drug Administration for essentially doubling down on a very silly law. The gist: South Mountain Creamery, the dairy producer owned by the Sowerses, want to sell milk without the addition of any synthetic chemicals. To do this, they...
  • Memo to FDA Administrator Gottlieb: Help Entrepreneurs, Don't Hinder Them

    04/05/2018 2:56:15 PM PDT · by Kaslin · 2 replies
    Townhall.com ^ | April 5, 2018 | Ken Blackwell
    Thanks in large part to President Trump’s aggressive deregulation agenda—through which the president has demonstrated a commitment to cutting or restructuring unnecessary, burdensome rules that hamper innovation and growth—the economy is booming. Unfortunately, one poorly considered rule that seems to have escaped his notice will hurt the businesses that provide one of America’s favorite foods: pizza.The U.S. Food and Drug Administration’s (FDA) rule, a byproduct of the Patient Protection and Affordable Care Act and slated to go into effect on May 7, will require businesses with 20 or more locations that sell highly customizable food items—such as pizza companies, convenience stores, supermarkets...
  • Reducing Nicotine in Cigarettes Is an Extremely Bad Idea

    04/05/2018 12:23:20 AM PDT · by kathsua · 43 replies
    Janitor's view ^ | 04/04/18 | Reasonmclucus
    The Food and Drug Administration's proposal to gradually reduce nicotine levels in tobacco to discourage smoking is an extremely bad idea which won't help anyone and could hurt some. Smoking may appear unattractive to non-smokers, but smokers may be doing what is best for someone with their genetic brain structure. I have never had any connection to the tobacco industry. I have never smoked, owned any tobacco company assets or worked in a facility that sold tobacco products. People I cared about have died from medical conditions associated with tobacco use. On a personal level I don't understand how people...
  • FDA takes first step in drafting rule to cut nicotine levels in cigarettes

    03/15/2018 10:14:39 AM PDT · by GIdget2004 · 36 replies
    The Hill ^ | 03/15/2018 | Lydia Wheeler
    The Food and Drug Administration (FDA) on Thursday took the first step in creating a new rule to reduce the level of nicotine allowed in cigarettes to nonaddictive levels. In an advanced notice of proposed rulemaking, FDA asked the public to submit comments over the next 90 days on the impact of a product standard for the maximum nicotine level in cigarettes. “Tobacco use causes a tremendous toll of death and disease every year and these effects are ultimately the result of addiction to the nicotine contained in combustible cigarettes, leading to repeated exposure to toxicants from such cigarettes,” the...
  • New Antibiotic for MRSA Infections is Ready for US Clinical Trials

    02/27/2018 9:53:11 AM PST · by nickcarraway · 15 replies
    Labiotech ^ | Alex Dale Alex Dale on 26/02/2018 | Alex Dale Alex Dale on 26/02/2018
    Destiny Pharma’s antibiotic for post-surgical infections will begin its clinical development after the FDA accepted its Investigational New Drug application. Destiny Pharma wants to combat the growing antibiotic resistance crisis by targeting post-surgical Staphylococcus aureus infections like methicillin-resistant Staphylococcus aureus (MRSA). The FDA has accepted an investigational new drug application (IND) for Destiny’s MRSA candidate, XF-73, which will allow the company to complete Phase I and finalize the design of a Phase II trial. XF-73 is a dicationic porphyrin molecule, which is a member of a new class of antibiotics called XF drugs. Interestingly, XF-73 is a nasal gel, which...