Judge gives FDA just over eight months to produce Pfizer’s safety data

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The decision rejects the FDA’s request to release the data over what would be 75 years Mimi Nguyen Ly A federal judge Thursday, Jan. 6, ordered the U.S. Food and Drug Administration to produce, at a rate of 55,000 pages per month, the documents it relied on to license the Pfizer-BioNTech COVID-19 vaccine. The rate of 55,000 pages a month would mean the FDA has just over eight months to fully produce all of Pfizer’s pre-licensure safety data. That is much faster than the 500 pages-per-month rate the FDA proposed in December 2021. That rate would have effectively given the agency roughly 75 years to fully produce the data, Aaron Siri, a lawyer working on the case, previously observed. U.S. District Judge Mark Pittman ordered the FDA to produce more than 12,000 pages on
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