Dozens of major hospitals may ignore an FDA decision allowing use of plasma from recovered COVID-19 patients in order to focus on a clinical trial.
, dubbed PassItOnII, which has also received funding from country music superstar Dolly Parton. The trial, which aims to enroll 1,000 adult hospitalized patients, could meet its goals by the end of October. If it shows evidence of likely benefit to COVID-19 patients, it could immediately change clinical practice, Rice said.
Though the trial launched in April, enrollment has been slow. The funding allows enlistment at more than 50 sites nationwide. That has spurred new conversations about joining the trial — and about not employing the controversial authorization issued by the FDA, said
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Doctors alarmed as FDA floats 'emergency use' of COVID-19 vaccine, bypassing trials“It’s a lesser review, it’s a lower-quality review, and when you’re talking about vaccinating a large chunk of the American population, that’s not acceptable,” said one vaccine expert.
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FDA says outside pressure won't influence COVID-19 vaccine approvalThe commissioner said, depending on that data, it&39;s possible a vaccine could be available by Election Day and before a Phase III trial is completely finished.
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FDA to bring outside experts to review COVID-19 vaccinesThe U.S. Food and Drug Administration will organize meetings with independent group of experts to review data of coronavirus vaccine candidates and advice the agency, FDA commissioner Stephen Hahn said on Wednesday.
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FDA Promises To Fast-Track Cure For Side Effects Of Fast-Tracked Covid VaccineWASHINGTON—Declaring that they had already earmarked tens of millions of dollars toward funding the vital medication, the FDA reportedly promised Tuesday to fast-track a cure for the side effects of the fast-tracked Covid-19 vaccine. “Developing a response to address the effects of the accelerated coronavirus vaccine, whatever they end up being, is our number-one priority,” said FDA commissioner Stephen Hahn, adding that the agency planned to bypass phase three testing and get the cure out on the market before the most debilitating side effects of the administration’s Covid-19 vaccine became permanent. “Once we have the initial data in place that tell us whether the coronavirus vaccine causes, for example, profuse vomiting, excruciating pain, or organ failure, we’ll be able to ensure that a cure will be available to Americans shortly after the vaccine. We know how much widespread suffering the coronavirus has caused, and how much widespread suffering a fast-tracked, minimally tested vaccine is likely to cause, so we’re working to keep a cure for the as-yet-unknown side effects a top priority.” FDA officials additionally confirmed they were also preparing to fast-track a cure for the side effects of the fast-tracked cure for the side effects of the coronavirus vaccine. \n
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FDA shake-up continues as another comms official removed from top roleAnother Trump appointee has been removed from a top communications post at FDA, continuing a shake-up of the agency’s media strategy after the troubled rollout of a coronavirus treatment authorization
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Second Trump appointee out at FDA amid credibility concernsA second Trump administration appointee has been ousted at the Food and Drug Administration after the agency's botched announcement about an experimental therapy for COVID-19. Experts say the announcement damaged the health regulator's credibility.
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