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FDA commissioner Marty Makary says the agency is undertaking a major hiring push and a series of operational reforms aimed at stre...[ Price : $8.95]
FDA releases the form FDA-483 with six observations from an inspection at Chinas Bio-Thera Solutions.[ Price : $8.95]
FDA awards Partner Therapeutics a Commissioners National Priority Voucher for a new Bizengri indication.[ Price : $8.95]
FDA publishes a guidance explaining how the agency uses a flexible chemistry, manufacturing, and controls approach to help expedit...[ Price : $8.95]
FDA hosts a virtual public meeting later this month to address industry questions tied to a planned pilot program exploring the us...[ Price : $8.95]
FDA warns Czechias Respilon Production about CGMP violations in its manufacturing of over-the-counter drugs.[ Price : $8.95]
A Bioprocess Online guest column outlines recent changes to FDAs accelerated approval pathway that were made to address systemic f...[ Price : $8.95]
TransCelerate reports on a 2025 tabletop exercise it convened with the CDER Center for Clinical Trial Innovation that focused on s...