Tag Archives: FDA

BREAKING: FDA Advisory Panel OK’s Pfizer Vaccine

Forbes reports: Members of FDA’s Vaccine and Related Biological Products Advisory Committee endorsed Pfizer and BioNTech’s Covid-19 vaccine candidate on Thursday, clearing the last hurdle before emergency use authorization from the federal agency. The committee, also called VRBPAC, met for nine hours to discuss all aspects of the new Covid-19 vaccine, from risk and safety to how Pfizer and BioNTech …

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Recall: Antidepressant Accidentally Mixed With Viagra

Via press release from the FDA: AvKARE, Pulaski, TN is voluntarily recalling one lot of Sildenafil 100 mg tablets and one lot of Trazodone 100mg tablets to the consumer level. These products have been recalled due to a product mix-up of the listed two separate products inadvertently packaged together during bottling at a 3rd party facility. Unintentional consumption of sildenafil …

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LIVE VIDEO: FDA Decides On Pfizer Vaccine Approval

The Hill reports: The U.S. Food and Drug Administration’s vaccines and related biological products advisory committee on Thursday morning is set to discuss Pfizer’s request for emergency use authorization of its COVID-19 vaccine. The hearing is scheduled to begin at 9AM Eastern. CNBC reports: The non-binding decision from the agency’s Vaccines and Related Biological Products Advisory Committee, an outside group …

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FDA Approves First OTC At-Home COVID Test Kit

CNN reports: The US Food and Drug Administration has granted an emergency use authorization for the first non-prescription, over-the-counter Covid-19 test kit for at-home use. The LabCorp Pixel COVID-19 Test Home Collection Kit allows anyone 18 and older to buy the kit and collect nasal swab samples at home, the FDA said in a news release Wednesday. The samples are …

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FDA: Pfizer Vax Provides Protection After First Dose

The New York Times reports: The coronavirus vaccine made by Pfizer and BioNTech provides strong protection against Covid-19 within about 10 days of the first dose, according to documents published on Tuesday by the Food and Drug Administration before a meeting of its vaccine advisory group. The finding is one of several significant new results featured in the briefing materials, …

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WH Summons FDA Head Over Vax Approval Speed

Axios reports: White House Chief of Staff Mark Meadows has summoned FDA commissioner Stephen Hahn to the West Wing for a 9:30am meeting Tuesday to explain why he hasn’t moved faster to approve the Pfizer coronavirus vaccine, two senior administration officials told Axios. The meeting is shaping up to be tense, with Hahn using what the White House will likely …

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Doctors Worry Vaccine Side Effects May Deter Patients

CNBC reports: Public health officials and drugmakers must be transparent about the side effects people may experience after getting their first shot of a coronavirus vaccine, doctors urged during a meeting Monday with CDC advisor. Dr. Sandra Fryhofer of the AMA noted that both Pfizer’s and Moderna’s vaccines require two doses at varying intervals. She said she worries whether her …

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FDA Approves Antibody Treatment Given To Trump

The New York Times reports: The Food and Drug Administration has granted emergency authorization for the experimental antibody treatment given to President Trump shortly after he was diagnosed with Covid-19, giving doctors another option to treat Covid-19 patients as cases across the country continue to rise. The emergency authorization for Regeneron’s drug is limited in scope: It is for people …

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FDA Approves First At-Home 30-Minute COVID Test

Via press release from the FDA: Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 …

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Pfizer Close To Seeking FDA Approval For Vaccine

STAT News reports: Pfizer may be within days of filing for an emergency use authorization for its Covid-19 vaccine, having collected the safety data necessary to submit an application to the Food and Drug Administration, CEO Albert Bourla said Tuesday. “We are very close to submitting for an emergency use authorization,” Bourla said during the STAT Summit, which this year …

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FDA Approves Antibody Drug Given To Chris Christie

The New York Times reports: The Food and Drug Administration has granted emergency authorization of a Covid-19 treatment made by the American pharmaceutical company Eli Lilly that was given to Chris Christie, the former New Jersey governor, when he was infected with the coronavirus. The authorization, announced on Monday, applies only to people newly infected with the virus, and the …

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Former FDA Head Calls For National Mask Mandate

Scott Gottlieb writes for the Wall Street Journal: As a practical matter, it’s easier to wear a mask in the winter than the summer. A mandate can be expressly limited to the next two months. The inconvenience would allow the country to preserve health-care capacity and keep more schools and businesses open. Studies show widespread use of masks can reduce …

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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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