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Postapproval manufacturing changes for biological products During clinicaldevelopment or following a product’s approval , sponsors and/or manufacturers may identify the need for a change in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling. Comments are due September 23, 2024.
27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame. The company announced the initiation of its Phase 1b clinical trial to evaluate the safety of a novel investigational therapeutic for COVID-19, PF-07304814.
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