A group seeking all the documents analyzed by U.S. drug regulators before approving Pfizer’s COVID-19 vaccine has reached an agreement with the government on how fast the documents will be produced. The Food and Drug Administration (FDA) must produce 10,000 pages by March 1 and another 10,000 pages by April 1 in response to the Freedom of Information Act request and subsequent lawsuit by the Public Health and Medical Professionals for Transparency, according to the agreement, which was approved by the judge overseeing the case on Feb. 2. The FDA must then produce 80,000 additional pages in three tranches, one due May 2, one due June 1, and one due July 1. The regulatory agency was ordered to produce 70,000 pages by Aug. 1 and then 55,000 pages on or before the first business of each month thereafter. The amendment to the production requirement keeps the total schedule at about 8 …
FDA, Doctors’ Group Reach Agreement on Production of Pfizer Vaccine Documents
February 5, 2022
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