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FDA posts a new guidance detailing how manufacturers should design and submit regulatory applications for patient-matched guides u...[ Price : $8.95]
Some 30 bipartisan House members urge FDA to expedite its review of new mental health therapies.[ 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...[ Price : $8.95]
New reporting reveals that FDA has withdrawn or blocked the publication of multiple internal studies supporting the safety of Covi...[ Price : $8.95]
FDA warns Orlando, FL-based Active Cosmetics Manufacturing about CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA warns Unetixs Vascular about illegally marketing adulterated and misbranded vascular diagnostic ultrasound devices.