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Keyword: fda

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  • Philippine FDA: Another hospital allowed to use Ivermectin to Treat Covid-19, The Second In the Country

    04/16/2021 6:36:05 PM PDT · by SeekAndFind · 10 replies
    Philstar via MSN ^ | 04/16/2021 | Sheila Crisostomo
    MANILA, Philippines — Another private hospital was given a Compassionate Special Permit (CSP) to use Ivermectin as treatment for COVID-19 patients, the Food and Drug Administration (FDA) said yesterday. According to FDA director general Eric Domingo, there are now two private hospitals, which he refused to identify, that can use the mainly veterinary drug to treat their COVID-19 patients. “As of (Thursday), there was a second hospital applicant for CSP. (Yesterday) morning, it was approved already,” he noted. The CSP is valid for one year and can only be used by doctors of these hospitals. But Domingo stressed there is...
  • Was Johnson & Johnson shafted by the FDA? The mRNA vaccines, Pfizer and Moderna have far more reported cases of thrombosis

    04/16/2021 9:35:08 AM PDT · by SeekAndFind · 51 replies
    NOQ Report ^ | 04/16/2021 | Ray Fava
    In a move much like the European nations who halted the distribution of the Astra-Zeneca vaccine, the Food and Drug Administration called for an immediate halt to the rollout of the Johnson & Johnson vaccine. This came after it was reported that six women between the ages of 18 and 48 reported blood clots and one died, after taking the vaccine. The move is odd. General reactions from social media are memes about the J&J vaccine’s supposed inferiority and skepticism of what is really going on with this particular vaccine. Many believe that there may be a coverup at works....
  • Federal Government Caught Buying ‘Fresh’ Flesh Of Aborted Babies Who Could Have Survived As Preemies

    04/15/2021 6:43:28 AM PDT · by Kaslin · 23 replies
    The Federalist ^ | April 15, 2021 | Edie Heipel
    Americans should be outraged their government participates in the wide-scale human trafficking operation that created a market for harvesting the organs of murdered infants.This article contains disturbing information about human dismemberment.Last week, legal accountability group Judicial Watch dropped a bombshell: a nearly 600-page report proving the U.S. government has been buying and trafficking “fresh” aborted baby body parts. These body parts, purchased by the U.S. Food and Drug Administration to “humanize” mice and test biologic drugs in scientific experiments, came from babies up to 24-weeks-old gestation, just weeks from being born.While Americans may be used to hearing pro-lifers beat the...
  • US agency says women can get abortion pill via telemedicine [FDA]

    04/13/2021 1:04:48 PM PDT · by Olog-hai · 1 replies
    Associated Press ^ | April 13, 2021 | Matthew Perrone
    Women seeking an abortion pill will not be required to visit a doctor’s office or clinic during the COVID-19 pandemic, U.S. health officials said Tuesday in the latest reversal in an ongoing legal battle over the medication. The Food and Drug Administration announced the policy change in a letter to the American College of Obstetricians and Gynecologists, one of several medical groups that has sued over the restriction put in place under the Trump administration. The FDA’s acting head, Dr. Janet Woodcock, said an agency review of recent studies “do not appear to show increases in serious safety concerns,” when...
  • FDA and CDC call for 'pause' on Johnson & Johnson COVID-19 vaccine after blood clot reports ... 6 women suffered blood clots in days after Johnson and Johnson vaccine

    04/13/2021 7:51:36 AM PDT · by Red Badger · 58 replies
    https://abc13.com ^ | Tuesday, April 13, 2021 9:42AM | Staff
    <p>WASHINGTON -- The U.S. is recommending a "pause" in administration of the single-dose Johnson & Johnson COVID-19 vaccine to investigate reports of potentially dangerous blood clots.</p><p>In a joint statement Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration said they were investigating clots in six women that occurred in the days after vaccination. The clots were observed along with reduced platelet counts - making the usual treatment for blood clots, the blood thinner heparin, potentially "dangerous."</p>
  • Regeneron to request FDA clearance to use Covid antibody drug as a preventative treatment

    04/12/2021 10:20:21 AM PDT · by Blue Turtle · 17 replies
    “With more than 60,000 Americans continuing to be diagnosed with COVID-19 every day, the REGEN-COV antibody cocktail may help provide immediate protection to unvaccinated people who are exposed to the virus,” Dr. George Yancopoulos, president and chief scientific officer at Regeneron, said in a press release.
  • Ivermectin: There is No compassion in compassionate use

    04/11/2021 8:00:48 PM PDT · by SeekAndFind · 75 replies
    Philstar Global ^ | 04/11/2021 | Cito Beltran
    In our collective battle in the Philippines against COVID-19 and its minions or variants there is now a great divide. On one side are the men and women from all professions and expertise who seek any and all remedies, possibilities and solutions to save lives, cure those infected and prevent further destruction and infections from taking place. They are the ones that have pushed for many new techniques, doing away with certain treatments for certain patients, improving handling, using different kinds of medicines for “Off Label” use such as Hydroxychloroquine, Ivermectin, Remdesivir, Leronlimab and others. On the dark side of...
  • Philippines: Hospital granted a special permit to use Ivermectin for Covid-19 ‘eligible’ to secure FDA approval — Director General Eric Domingo

    04/09/2021 12:47:23 PM PDT · by SeekAndFind · 17 replies
    Manila Bulletin ^ | 04/09/2021 | Ellalyn De Vera-Ruiz
    Philippine Food and Drug Administration (FDA) Director General Eric Domingo said the agency has granted the “compassionate use” of Ivermectin to a certain hospital because it was “eligible” and has passed the requirements. We will not issue a CSP [compassionate special permit] if the hospital is not eligible,” Domingo said in a Department of Health briefing on Friday, April 9. That’s why it was given a CSP because the hospital applied and it submitted all the requirements,” he added. Domingo explained that a doctor or hospital can request for a compassionate special permit (CSP) if a drug is not available...
  • Please Don't Use Horse Deworming Drugs To Treat COVID-19, FDA Warns

    04/09/2021 12:35:47 PM PDT · by SeekAndFind · 88 replies
    IFLScience ^ | 04/09/2021 | Tm Hale
    Plenty of unapproved, dubious, or downright dangerous COVID-19 treatments have come and gone over the past year, but the US Food and Drug Administration (FDA) has come out with a refresher warning after a number of people have fallen sick using horse deworming drugs to treat COVID-19. The drug is ivermectin, a cheap and widely available medication used to treat parasite infestations. In humans, it’s used to treat head lice and scabies, as well as roundworms, and it’s also widely used on animals to treat parasitic worms. However, the products used to treat humans are different from the ones used...
  • RFK, Jr. to Rutgers President: COVID Vaccine Mandate Violates Federal Law

    04/02/2021 7:43:40 PM PDT · by yelostar · 33 replies
    childrenshealthdefense.org ^ | 03/29/21 | Children's Health Defense Team
    The announcement last week by Rutgers University that it would require all students to get the COVID vaccine prompted CHD Chairman Robert F. Kennedy, Jr., to remind university officials that federal law prohibits mandating Emergency Use Authorization vaccines.Rutgers University last week announced it will require all students enrolled for the 2021 fall semester to be vaccinated for COVID-19. The announcement prompted Children’s Health Defense (CHD) Chairman Robert F. Kennedy, Jr. to remind university officials that federal law prohibits mandating products approved under the U.S. Food and Drug Administration’s Emergency Use Authorization (EUA). In a letter to Rutgers President Jonathan Holloway,...
  • Supreme Court Fails Americans on Clinton Emails [Weely Update]

    04/02/2021 5:15:07 PM PDT · by jazusamo · 16 replies
    Judicial Watch ^ | April 2, 2021 | Tom Fitton
    More Shocking Details of FDA Purchases of Fetal Tissue — Agency Wanted “Fresh, Shipped on Wet Ice” Fetal Organs Supreme Court Drops the Ball on Clinton Email Testimony Judicial Watch at the Supreme Court: Fighting for Clean Elections Released Illegal Aliens Commit Home Invasions, Robberies, Store Burglaries Happy Easter! More Shocking Details of FDA Purchases of Fetal Tissue — Agency Wanted “Fresh, Shipped on Wet Ice” Fetal Organs The sale of body parts harvested during abortions is not generally understood, certainly not the gruesome details of the transactions. More grotesque details emerge in 575 pages of records we received...
  • Xlear Submits COVID-19 Pre-Emergency Use Authorization Request with FDA Regarding Use of Xlear Nasal Spray in Help in Combating SARS-CoV-2

    03/29/2021 9:43:50 PM PDT · by SeekAndFind · 24 replies
    Business Wire ^ | 03/29/2021
    WASHINGTON--(BUSINESS WIRE)- Xlear has filed a Pre-Emergency Use Authorization (Pre-EUA) Request with the U.S. Food and Drug Administration (FDA) seeking approval to make claims that the nasal spray is approved for use in preventing SARS-CoV-2 (COVID-19) transmission and infection. The Pre-EUA is a first step in seeking formal authorization of Xlear Nasal Spray as tool to help in combatting COVID-19. Xlear previously filed a pre-EUA seeking approval for use of the nasal spray as a medical device in combatting COVID-19. However, because the FDA determined that Xlear “works against the virus,” the FDA told Xlear it would need to be...
  • Vaccine passports?

    03/29/2021 9:01:36 AM PDT · by upchuck · 45 replies
    Various | March 29, 2021 | Vanity
    How will the passport Nazis get past the FDA? Look at this from statnews.com first:Federal law prohibits employers and others from requiring vaccination with a Covid-19 vaccine distributed under an EUAThen look at this PDF from the FDA:Emergency Use Authorization of Medical Products and Related AuthoritiesGo to PDF page 28 and look under "Information for Recipients," then read the fourth bullet.Sure looks to me that as long as the FDA has an Emergency Use Authorization for the vaccines, you can't be forced to take it. The article from statnews.com says it can take two years for the FDA to drop...
  • White House promises more J&J COVID-19 shots after launch stalls

    03/22/2021 4:50:00 PM PDT · by BeauBo · 68 replies
    MSN ^ | 22 Mar 2021 | Carl O'Donnell and Michael Erman (Reuters)
    Johnson & Johnson should come close to hitting its target of delivering 20 million doses of its one-shot COVID-19 vaccine in March after its shipments stalled in recent weeks, a top White House official said on Monday (22 Mar)... The company shipped four million shots in early March but its rollout has since stalled as facilities involved in the manufacturing await clearance from the U.S. Food and Drug Administration. ...far less than the 20 million it promised to deliver by the end of March... J&J did not immediately respond to requests for comment. Initial U.S. doses have been made at...
  • Former FDA Chief Says Social Distancing Mandate ‘Wasn’t Based on Clear Science’

    03/21/2021 7:11:05 PM PDT · by E. Pluribus Unum · 10 replies
    The Epoch Times ^ | March 21, 2021 14:30 | Jack Phillips
    Former Food and Drug Administration Commissioner Scott Gottlieb said that the six-foot social distancing mandate that was employed across much of the United States and the world to deal with the CCP virus pandemic “wasn’t based on clear science.” “This six-foot distancing requirement has probably been the single costliest mitigation tactic that we’ve employed in response to COVID … and it really wasn’t based on clear science. … We should have re-adjudicated this much earlier,” he said in an interview with CNBC. Amid the relaxation of CCP (Chinese Communist Party) virus guidelines—including one from the Centers for Disease Control and...
  • Former FDA Commissioner Says Social Distancing Mandate ‘Wasn’t Based on Clear Science’

    03/21/2021 1:38:54 PM PDT · by rxsid · 26 replies
    www.theepochtimes.com ^ | 03.21.2021 | Jack Phillips
    Former FDA Commissioner Says Social Distancing Mandate ‘Wasn’t Based on Clear Science’Former Food and Drug Administration Commissioner Scott Gottlieb said that the six-foot social distancing mandate that was employed across much of the United States and the world to deal with the CCP virus pandemic “wasn’t based on clear science.”“This six-foot distancing requirement has probably been the single costliest mitigation tactic that we’ve employed in response to COVID … and it really wasn’t based on clear science … we should have re-adjudicated this much earlier,” he said in an interview with CNBC. In the midst of relaxation of CCP (Chinese...
  • Lawsuit for Info on Capitol Police Officer Death [Weekly Update]

    03/19/2021 4:09:34 PM PDT · by jazusamo · 13 replies
    Judicial Watch ^ | Tom Fitton
    Judicial Watch Sues for Autopsy of Capitol Police Officer Brian Sicknick Judicial Watch Sues for NY, PA COVID Nursing Homes Policies Court Slams Potentially Illicit Sales of Parts of Aborted Fetuses U.S. Lifts Yemeni Militant Group’s Terrorist Designation Judicial Watch Sues for Autopsy of Capitol Police Officer Brian Sicknick We’re not going to get the full truth of events at the Capitol on January 6 from politicians or a dishonest media — no surprise there. So were going after it on our own. We filed a District of Columbia Freedom of Information Act (FOIA) lawsuit in the District of...
  • FDA warns not to drink Real Water-brand alkaline water after 5 kids hospitalized with liver illness

    03/18/2021 1:12:06 PM PDT · by BenLurkin · 30 replies
    Company President Brent Jones on Wednesday called for stores to stop selling the product “throughout the United States until the issue is resolved.” “Our goal is to diligently work with the FDA to achieve a swift resolution,” a statement from Jones said. The U.S. Food and Drug Administration warned consumers, restaurants and retailers not to drink, cook with, sell or serve the product, the Southern Nevada Health District said in a statement posted Tuesday. Real Water is marketed in boxy blue plastic bottles as mineral-rich and “alkalized” and “infused with negative ions.” Acute non-viral hepatitis is a liver inflammation that...
  • Promising At-Home Treatment for COVID-19 Discovered: FDA Approved Drug for Leprosy

    03/16/2021 11:36:24 AM PDT · by Red Badger · 15 replies
    https://scitechdaily.com ^ | MARCH 16, 2021 | By SANFORD BURNHAM PREBYS MEDICAL DISCOVERY INSTITUTE
    Testing in the lab at Sanford Burnham Prebys Medical Discovery Institute. Credit: Sanford Burnham Prebys Medical Discovery Institute Phase 2 clinical trial could begin immediately for clofazimine, an FDA-approved drug on WHO’s List of Essential Medicines. A Nature study authored by scientists at Sanford Burnham Prebys Medical Discovery Institute and the University of Hong Kong shows that the leprosy drug clofazimine, which is FDA approved and on the World Health Organization’s List of Essential Medicines, exhibits potent antiviral activities against SARS-CoV-2 and prevents the exaggerated inflammatory response associated with severe COVID-19. Based on these findings, a Phase 2 study evaluating...
  • the mRNA shots are not legally, or medically, "vaccines" - you are being lied to deliberately

    if you dont read the link, heres the key points: “This is an mRNA, packaged in a fat envelope, delivered to a cell. This is a medical device designed to stimulate the human cell into becoming a pathogen creator.” “...under CDC and FDA standards, a vaccine specifically has to stimulate, both an immunity within the person receiving it but it also has to disrupt transmission. And that’s not what this is. They have been abundantly clear in saying that the mRNA strand going into the cell is not to stop transmission. It is a treatment.”