As new cancer vaccines—led by Moderna and Merck’s mRNA-4157—near pivotal trial readouts, the FDA’s vaccines czar Peter Marks, M.D., Ph.D., said the agency is ready to review the shots despite AI-related unknowns. “We are ready to review—we’re open for business,” Marks, director of the FDA’s Center for Biologics Evaluation and […]
FOIA’d FDA ‘Establishment Inspection Reports’ of Pfizer COVID Vaccine Manufacturing Facilities Reveal “Inadequate Quality Oversight,” Deficient Deviation Investigations, Ignored Standard Operating Procedures, and More.
Amy Kelly, COO of DailyClout.io and Project Director for the WarRoom/DailyClout Pfizer and Moderna Documents Analysis Project, received a partial production of documents in response to her Freedom of Information Act (FOIA) request submitted to the Food and Drug Administration (FDA) for “all FDA inspection reports from inspections of Pfizer […]