Tag Archives: FDA

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 …

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 …

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 …

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 …

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 …

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 …

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 …

“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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …