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Keyword: fda

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  • CDC’s Diagnostic Test for COVID-19 Only and Supplies

    07/11/2020 9:18:28 AM PDT · by LOC1 · 3 replies
    On June 12, 2020, the FDA granted an amendment to the EUA for the CDC diagnostic test used to detect COVID 19 to address global shortages of materials needed to perform the test. This amendment provides alternatives for processing the test: Four additional extraction reagents were approved that can be used in the existing extraction methods; An additional extraction instrument and associated reagents were approved; and a new process that can be used in place of the extraction method when materials for the current method are limited
  • Biden Scandal Update [Obama Effort to ‘Evolve’ Explanation Benghazi Attack] [Weekly Update]

    06/26/2020 3:50:23 PM PDT · by jazusamo · 17 replies
    Judicial Watch ^ | June 26, 2020 | Tom Fitton
    Revealed: Obama Effort to ‘Evolve’ Explanation of Benghazi Attack Secret Service: Hunter Biden Took 411 Flights, Visited 29 Countries, Including 5 Visits to China FDA Bought ‘Fresh’ Human Fetal Parts for ‘Humanized Mice’ Creation Supreme Court Protects Obama Illegal Amnesty It’s hard to keep your story straight if you’re making it up as you go along, which was the modus operandi of Obama fabricator Ben Rhodes. The Justice Department released 80 pages of records showing top Obama White House officials scrambling to “evolve” its false claims that the September 11, 2012, terrorist attacks on U.S. Government facilities in Benghazi,...
  • Judicial Watch Obtains Records Showing FDA Paid for ‘Fresh and Never Frozen’ Human Fetal Parts for Use In ‘Humanized Mice’ Creation

    06/23/2020 8:44:43 PM PDT · by bitt · 18 replies
    JUDICIAL WATCH ^ | 6/23/2020 | staff
    Judicial Watch announced today it received 165 pages of records from the Food and Drug Administration (FDA) showing the FDA between 2012 and 2018 entered into 8 contracts worth $96,370 with Advanced Bioscience Resources (ABR) to acquire “fresh and never frozen” tissue from 1st and 2nd trimester aborted fetuses for use in creating “humanized mice” for ongoing research. ABR is a non-profit firm which has been the subject of criminal referrals from House and Senate committees investigating whether Planned Parenthood or any other entity was illegally profiting from the handling of fetal tissue from aborted babies. Federal law regulates the...
  • FDA Terminates Hydroxychloroquine Emergency Authorization for COVID-19 despite therapeutic successes around the world, and significant usage by many doctors

    06/19/2020 7:52:31 AM PDT · by SeekAndFind · 21 replies
    Covexit ^ | 06/18/2020
    Despite therapeutic successes with hydroxychloroquine around the world, and significant usage by many doctors in the US, who regularly report success in using the drug, and despite the support for the drug by the US president, the Food and Drugs Administration today revoked its emergency authorization for COVID-19. The decision relies on “recent results from a large randomized clinical trial in hospitalized patients.” UPDATE: It appears the announcement will not prevent prescriptions of HCQ outside hospital settings. Check this video: FDA action today makes hcq MORE available to doctors and patients in outpatient setting. TREAT EARLY AND LIVE. ⁦Posted...
  • Dr. Fauci, health officials flag coronavirus risk of Trump’s Tulsa rally

    06/17/2020 9:19:07 PM PDT · by rintintin · 50 replies
    CNBC ^ | June 17 2020 | William Feuer
    The rally, Trump’s first since the coronavirus pandemic took hold in the U.S. over three months ago, is slated to take place Saturday in a 20,000-person indoor arena. Asked whether he would attend the rally, White House coronavirus advisor Dr. Anthony Fauci said in an interview published Wednesday by the Daily Beast, “of course not.” Former FDA chief Dr. Scott Gottlieb told CNBC on Wednesday, “Personally, I wouldn’t attend a large gathering right now, especially one indoors. Certainly things held indoors are less safe than things held outdoors.”
  • Doctors Can Still Prescribe Hydroxychloroquine to Patients, Says US Health Secretary as FDA Withdraws Emergency Use

    06/17/2020 9:00:04 PM PDT · by SeekAndFind · 29 replies
    Yahoo News ^ | 06/17/2020
    Doctors can still prescribe anti-malarial drug hydroxychloroquine to patients, US Health Secretary Alex Azar said, hours after the FDA withdrew the emergency use authorisation of chloroquine and HCQ in the treatment of COVID 19 patients. The US Food and Drug Administration's (FDA) decision came on Monday after it concluded that the anti-malarial drugs may not be effective to cure the virus infections and lead to greater risks than any potential benefits. "At this point, hydroxychloroquine (HCQ) and chloroquine are just like any other approved drug in the United States. They may be used in hospital, they may be used in...
  • Hydroxychloroquine: US stockpile stuck with 63 million doses of the drug after FDA revokes drug distribution for Coronavirus

    06/17/2020 8:28:17 PM PDT · by SeekAndFind · 48 replies
    CNN via MSN ^ | 06/17/2020 | By Elizabeth Cohen and Wesley Bruer, CNN
    The federal government is stuck with 63 million doses of hydroxychloroquine now that the US Food and Drug Administration has revoked permission for the drug to be distributed to treat coronavirus patients. The government started stockpiling donated hydroxychloroquine in late March, after President Trump touted it as "very encouraging" and "very powerful" and a "game-changer." But Monday, the FDA revoked its emergency use authorization to use the drug to treat Covid-19, saying there was "no reason to believe" the drug was effective against the virus, and that it increased the risk of side effects, including heart problems. That leaves the...
  • FDA withdraws emergency use authorization for Hydroxychloroquine for Coronavirus treatment

    06/15/2020 9:22:01 AM PDT · by SeekAndFind · 28 replies
    The Hill ^ | 06/15/2020 | BY NATHANIEL WEIXEL
    The Food and Drug Administration has withdrawn the emergency use authorization for two controversial coronavirus treatment drugs promoted by President Trump because of serious safety issues. The agency said recent clinical trial failures mean chloroquine and hydroxychloroquine may not be effective at treating COVID-19 or preventing it in people who have been exposed, and that their potential benefits do not outweigh the risks. Doctors have warned that the drugs can cause serious heart problems, but the FDA had previously allowed their use for hospitalized patients and during clinical trials. Trump spent weeks promoting the drugs as a potential miracle treatment...
  • Association of American Physicians and Surgeons Sues FDA for “Irrational” Interference of Access to Life-Saving Hydroxychloroquine

    06/15/2020 8:32:45 AM PDT · by bitt · 19 replies
    GATEWAY PUNDIT ^ | 6/14/2020 | Jim Hoft
    The Association of American Physicians and Surgeons ( filed a lawsuit against Department of Health and Human Services and the FDA for “irrational interference” by the FDA with timely access to hydroxychloroquine. Never in history have we seen such a determined effort by the scientific community and pharmaceutical industry to downplay and lie about the use of a successful drug to treat a deadly disease. Hydroxychloroquine is the first choice in a study of 6,000 doctors treating the coronavirus. In the field and in independent testing hydroxychloroquine displayed amazing results in treating the COVID-19 virus. But there was great pushback...
  • Association of American Physicians & Surgeons (AAPS) Sues the FDA to End Its Arbitrary Restrictions on Hydroxychloroquine to Treat Covid-19

    06/02/2020 11:51:07 AM PDT · by SeekAndFind · 6 replies
    oday the Association of American Physicians & Surgeons (AAPS) filed a lawsuit, AAPS v. FDA, against the Food and Drug Administration to end its arbitrary interference with the use of hydroxychloroquine (HCQ), which President Trump and other world leaders have taken as a prophylaxis against COVID-19. Two million doses of HCQ are being sent by the Trump Administration to Brazil to help medical workers there safeguard themselves against the spread of the virus. But at the same time the FDA continues to block Americans' access to this medication. HCQ has been approved as safe by the FDA for 65 years,...
  • FDA halts Bill Gates coronavirus testing program

    05/15/2020 8:03:38 PM PDT · by WWG1WWA · 51 replies
    The Hill ^ | 5/15/20 | Tal Axelrod
    The Food and Drug Administration (FDA) halted a coronavirus testing program promoted by billionaire Bill Gates and Seattle health officials pending reviews. The program sought to send test kits to the homes of people both healthy and sick to try to bring the country to the level of testing officials say is necessary before states can begin safely reopening. The program, which had already gone through thousands of tests, found dozens of cases that had been previously undiagnosed. The Seattle Coronavirus Assessment Network (SCAN) said on its website that the FDA had asked it to pause testing while it receives...
  • Bill Gates-Funded COVID-19 Tracking Program Shut Down by FDA

    05/15/2020 6:52:36 AM PDT · by Steve1999 · 24 replies
    NN ^ | 05-15-20 | Jay Greenberg
    A Bill Gates-funded COVID-19 tracking program has been shut down by the U.S. Food and Drug Administration (FDA), according to reports.The Seattle-based initiative, Seattle Coronavirus Assessment Network, or SCAN, has been ordered to halt its at-home coronavirus testing scheme by the federal authorities.
  • Trump administration preparing to require that some essential drugs be made in US: report

    05/14/2020 7:20:18 PM PDT · by yesthatjallen · 17 replies
    The Hill ^ | 05 14 2020 | J. Edward Moreno
    The White House is preparing to require that some essential drugs be made in the U.S. as the Trump administration tries to limit dependency on China for medical supplies, sources told CNBC. An executive order, proposed by White House trade advisor Peter Navarro, will streamline regulatory approvals for “American-made” products and impose similar Food and Drug Administration (FDA) restrictions on U.S. facilities as those abroad. It will also encourage government agencies to only buy American-made medical products. The order could reportedly come as soon as Friday. According to the FDA, 90 percent of drugs in the U.S. are imported, and...
  • Four Questions senators should ask Redfield and Fauci on Tuesday

    05/10/2020 7:01:31 AM PDT · by SeekAndFind · 17 replies
    American Thinker ^ | 05/10/2020 | Howard Richman
    On Tuesday, health bureaucrats Dr. Robert Redfield, director of the CDC, and Dr. Anthony Fauci, director of NIAID, will testify at a hearing of the Senate Health, Education, Labor and Pensions Committee. Republican Senators should ask them four questions about their failures to expedite deployment of vaccines and test the successful HCQ-zinc treatment during the COVID-19 pandemic. 1. Vaccine question for Redfield: Why haven’t you invoked the Accelerated Approval Process to get Moderna’s Vaccine out right away? During the H1N1 (Swine Flu) epidemic in 2009 when a Democrat was President, the CDC approved four vaccines just 7 weeks after...
  • Biotechnology Offers Hope for the World’s Hungry

    05/09/2020 4:42:37 AM PDT · by Kaslin · 10 replies ^ | May 9, 2020 | H. Sterling Burnett
    Amidst the human tragedy and media storm that is the coronavirus pandemic, it’s easy to lose sight of the fact that persistent threats to human health and well-being that pre-existed the COVID-19 still remain. Hunger and malnutrition, constantly simmering threats that only rarely get the attention of the pandemic de jour, kill and harm far more people every year than the coronavirus. This is worth remembering as the world recovers from the coronavirus crisis and life returns to a semblance of normality. Whatever the new normal will be, we should sustain and increase efforts to reduce premature mortality from starvation...
  • Souplantation’s buffet-style restaurants closing for good because of the coronavirus

    05/07/2020 10:00:57 PM PDT · by fluorescence · 73 replies
    Los Angeles Times ^ | May 7, 2020 | Lori Weisberg, Lucas Kwan Peterson
    Souplantation, the popular buffet-style dining brand founded in San Diego 42 years ago, is closing all of its restaurants permanently, a casualty of the COVID-19 pandemic that is likely to be the death knell for all self-serve eateries. The permanent closing of the 97 restaurants, including 44 in California, was announced Thursday after weeks of efforts to salvage San Diego-based Garden Fresh Restaurants, the parent company of Souplantation and Sweet Tomatoes. The closing will mean lost jobs for 4,400 employees. “The FDA had previously put out recommendations that included discontinuing self-serve stations, like self-serve beverages in fast food, but they...
  • The Media Is Blatantly Lying About Trump’s Coronavirus Response

    05/04/2020 11:48:02 AM PDT · by Kaslin · 20 replies
    The Federalist ^ | May 4, 2020 | David Marcus
    Conventional wisdom fueled by the media is that the White House ignored the coronavirus threat in January and February. It is absolutely false.There are times in the life of a body politic when conventional wisdom grows out of falsehoods. The danger of such a situation is that once it takes hold few people will actually look beyond the deception to discover the truth. We are living through just such a moment as much of our news media perpetrates a lie that the Trump administration was doing nothing to combat the novel coronavirus during January and February.Last week, The Federalist obtained...
  • FDA allows emergency use of remdesivir to treat coronavirus patients after promising study

    05/01/2020 2:23:23 PM PDT · by knighthawk · 38 replies
    Fox News ^ | May 01 2020 | Louis Casiano, James Rogers
    President Trump announced Friday that the Food and Drug Administration (FDA) has authorized the emergency use of Gilead Science's experimental antiviral drug remdesivir to treat coronavirus patients after early results of a clinical study indicated the drug helps speed recovery. Trump announced the news at the White House alongside Gilead CEO Daniel O’Day and FDA Commissioner Stephen Hahn. "FDA's emergency authorization of remdesivir, two days after the National Institutes of Health's clinical trial showed promising results, is a significant step forward in battling COVID-19 and another example of the Trump Administration moving as quickly as possible to use science to...
  • Let People Try Gelsolin!

    04/29/2020 8:34:20 AM PDT · by Kaslin · 11 replies
    Townhall .com ^ | April 29, 2020 | John Stossel
    We need new drugs to fight COVID-19 and other diseases. But our government's approval process makes that too hard. This year's pandemic got regulators to say they'll speed the approval process. The FDA adopted Emergency Use Authorization to speed up approval of some tests, medical equipment and ventilators. But that's not enough. I know about the FDA's rules because my older brother, Dr. Thomas Stossel, discovered something that might save a lot of lives. Doing medical research at Harvard, he found a protein in our blood that helps reduce excess inflammation. He named the protein gelsolin. Some inflammation is useful....
  • FBI Raids Detroit-Area Medical Facility 'For Using Intravenous Vitamin C to Treat COVID-19 Patients

    04/25/2020 1:07:03 PM PDT · by Hojczyk · 80 replies
    InformationLiberation ^ | Apr. 24, 2020 | Chris Menahan
    From Click on Detroit, "Macomb County business raided by the FBI over possible improper COVID-19 treatments": FBI agents went into building wearing full protective gear to protect themselves from potential exposure. Sources claim the raid is because Allure has been allegedly performing treatments for COVID-19 patients without an approved treatment or cure. On April 18, Allure’s Facebook page had a post that said "At Allure Medical, we have been using intravenous vitamin c therapy to treat COVID-19 in non-hospitalized patients with great results." That post, as well as a post on Allure Medical's official website on vitamin c treatments, has...