![]() ![]() That means all the Pfizer vaccine data should be public by the end of the summer rather than, say, the year 2097. Rather than producing 500 pages a month - the FDA's proposed timeline - he ordered the agency to turn over 55,000 a month. A clinical hold is an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. While Pittman recognized "the 'unduly burdensome' challenges that this FOIA request may present to the FDA," in his four-page order, he resoundingly rejected the agency's suggested schedule. The FDA didn't dispute it had an obligation to make the information public but argued that its short-staffed FOIA office only had the bandwidth to review and release 500 pages a month. District Judge Mark Pittman in Fort Worth, who was appointed to the bench by former President Donald Trump in 2019. Judge Orders FDA To Hasten Release of Pfizer Vaccine Docs Friday January 7, 2022. The court "concludes that this FOIA request is of paramount public importance," wrote U.S. That's roughly 75 years and four months faster than the FDA said it could take to complete a Freedom of Information Act request by a group of doctors and scientists seeking an estimated 450,000 pages of material about the vaccine. A federal judge in Texas on Thursday ordered the Food and Drug Administration to make public the data it relied on to license Pfizer’s COVID-19 vaccine, imposing a dramatically accelerated schedule that should result in the release of all information within about eight months. The US Food and Drug Administration (FDA) has been ordered to hasten the publication of documents related to Pfizer’s coronavirus vaccine by more than one-hundred-fold, after the agency claimed the disclosure would take decades. 'Paramount importance': Judge orders FDA to hasten release of Pfizer vaccine docs 01-08-2022Ī federal judge in Texas on Thursday ordered the Food and Drug Administration to make public the data it relied on to license Pfizer's COVID-19 vaccine, imposing a dramatically accelerated schedule that should result in the release of all information within about eight months. ![]()
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