Tag Archives: FDA

FDA Head: “Science Will Guide Our Vaccine Decisions”

“Decisions to authorize and approve any such vaccine or therapeutic will be made by the dedicated career staff at FDA through our thorough review processes and science will guide our decisions. “FDA will not permit any pressure from anyone to change that. I will fight for science, Mr. Chairman. I will fight for the integrity of the agency, and I …

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FDA To Issue New Strict Standard For COVID Vaccine, Will Be Unlikely Vaccine Will Come Before Election Day

The Washington Post reports: The Food and Drug Administration is expected to spell out a tough, new standard for an emergency authorization of a coronavirus vaccine as soon as this week that will make it exceedingly difficult for any vaccine to be cleared before Election Day. The agency is issuing the guidance to boost transparency and public trust as it …

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HHS Sec Overrode FDA Concerns On Testing Quality

Politico reports: Health and Human Services Secretary Alex Azar led an escalating pressure campaign against his own FDA this spring and summer, urging the agency to abandon its responsibility for ensuring the safety and accuracy of a range of coronavirus tests as the pandemic raged.  Then in late August, Azar took matters into his own hands. Overriding objections from FDA …

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FDA Commissioner Willing To Fast-Track COVID Vaccine

The New York Post reports: The head of the US Food and Drug Administration is willing to fast-track a coronavirus vaccine as quickly as possible – even before Phase Three clinical trials end — as long as officials are convinced the benefits outweigh the risks, according to a report. Commissioner Stephen Hahn told the Financial Times that the move would …

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FDA Chief Cans New Spox After Plasma Controversy

Politico reports: FDA Commissioner Stephen Hahn [photo] is ousting his top spokesperson after only two weeks on the job, in a move that follows unhappiness with the agency’s communications strategy, according to an email he sent to senior leaders on Friday that was shared with POLITICO. “Effectively immediately, Emily Miller will no longer serve the FDA as the assistant commissioner …

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FDA Caves To Trump, Approves Convalescent Plasma

The New York Times reports: The Food and Drug Administration late on Sunday gave emergency approval for expanded use of antibody-rich blood plasma to help hospitalized coronavirus patients, allowing President Trump, who has been pressuring the agency to move faster to address the pandemic, to claim progress on the eve of the Republican convention. Mr. Trump cited the approval, which …

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FDA Halts Approval For Plasma COVID Treatment

The New York Times reports: Last week, just as the Food and Drug Administration was preparing to issue an emergency authorization for blood plasma as a Covid-19 treatment, a group of top federal health officials including Dr. Francis S. Collins and Dr. Anthony S. Fauci intervened, arguing that emerging data on the treatment was too weak. The authorization is on …

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Trump Admin Blew $21M On “Laughable” Pepcid Study

The Associated Press reports: In early April, when government scientists learned of a proposal to spend millions in federal research funding to study Pepcid, they found it laughable, according to interviews, a whistleblower complaint and internal government records obtained by The Associated Press. But that didn’t stop the Trump administration from granting a $21 million emergency contract to researchers trying …

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Ex-FDA Chief Says US Could Hit 300K Deaths In 2020

CNBC reports: Former Food and Drug Administration (FDA) commissioner Doug Gottlieb signaled Wednesday that the U.S. could reach 300,000 COVID-19 deaths by the end of 2020 if the country’s death rate doesn’t improve. “Right now we have close to 1,000 casualties a day; so if we don’t change that trajectory, you could do the math and see where we are …

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Ex-FDA Commissioner: We’re Back At “Peak Epidemic”

Mediaite reports: CBS’s Face The Nation host Margaret Brennan asked former FDA Commissioner Scott Gottlieb where the U.S. is heading right now and he answered, “We’re right back where we were at the peak of the epidemic during the New York outbreak.” “The difference now is that we really had one epicenter of spread when New York was going through …

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FDA Retreats From Trump’s Claim Of Vaccine This Year

The Hill reports: In a Fourth of July address in Washington, D.C., on Saturday, Trump said that the U.S. was unleashing its “scientific brilliance” toward developing treatments for COVID-19, the disease caused by the novel coronavirus. “And we’ll likely have a therapeutic and/or vaccine solution long before the end of the year,” Trump said. “I can’t predict when a vaccine …

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FDA Issues Recall After Salad Parasite Sickens 100+

ABC News reports: The Food and Drug Administration today has recalled bagged salad distributed to a dozen Midwestern states by Hy-Vee, Aldi and Jewel-Osco grocery stores after 122 people in seven states were sickened. Nineteen have been hospitalized. The salad mix is contaminated with cyclospora, a parasite that can cause severe diarrhea. The salad mix is packaged as Hy-Vee Brand …

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FDA Warns Against Nine “Toxic” Hand Sanitizer Brands

CBS News reports: U.S. consumers should not use any of nine brands of possibly toxic hand sanitizer that may contain methanol, or wood alcohol, a substance that’s potentially dangerous when absorbed through the skin or ingested, the Food and Drug Administration warned. The agency’s alert comes at a time when hand sanitizers are in especially heavy demand due to the …

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FDA Withdraws Approval For Drug Touted By Trump

The Washington Post reports: The Food and Drug Administration has withdrawn its emergency use authorization for hydroxychloroquine to treat coronavirus patients. President Trump had repeatedly promoted the antimalarial drug as a way to prevent or treat covid-19. The agency said Monday in a statement that “it is no longer reasonable to believe” the drug may be effective against covid-19 or …

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FDA Gives Approval For New At-Home COVID Test Kit

Axios reports: An at-home coronavirus collection kit made by health care startup Everlywell has received emergency authorization from the Food and Drug Administration, the agency announced Saturday. This is the only kit that can be used with multiple coronavirus tests, although two other at-home swabs have received authorization from the FDA. The swabs collected at home will be sent to …

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FDA Gives WH New Guidance On Rapid COVID Test

The Associated Press reports: The head of the Food and Drug Administration said Friday his agency has provided new guidance to the White House after data suggested that a rapid COVID-19 test used by President Donald Trump and others every day may provide inaccuracies and false negatives. Commissioner Steve Hahn said that if a person is suspected of having the …

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FDA Head In Quarantine Due To Pence’s COVID+ Spox

Reuters reports: U.S. Food and Drug Administration Commissioner Stephen Hahn is in self-quarantine for a couple of weeks after coming into contact with someone who tested positive for COVID-19, an FDA spokesman told Reuters late on Friday. Hahn immediately took a diagnostic test and was tested negative himself for the novel coronavirus, FDA spokesman Michael Felberbaum said in an emailed …

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Ex-FDA Head: Ouster Of Vaccine Chief “Sets Us Back”

The Hill reports: Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb said Sunday that the ouster of federal vaccine chief Richard Bright will “set us back” in combating the coronavirus pandemic. “I know Rick Bright well … he was effective. He was a vaccine expert, so I was sorry to see him go,” Gottlieb said on CBS’ “Face the …

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FDA Issues Heart Risk Warning On Trump’s Drugs

Bloomberg News reports: The U.S. Food and Drug Administration warned patients against taking two malaria medications that have been talked up by President Donald Trump for Covid-19, unless carefully monitored in a hospital or as part of a clinical trial. The FDA said it was issuing the warning for the drugs, hydroxychloroquine and chloroquine, after reports that patients taking them, …

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FDA Approves First In-Home Coronavirus Testing Kit

The New York Times reports: The Food and Drug Administration on Tuesday said it had granted emergency clearance to the first in-home test for the coronavirus, a nasal swab kit that will be sold by LabCorp. The agency said that LabCorp had submitted data showing the home test is as safe and accurate as a sample collection at a doctor’s …

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