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FDA warns Unetixs Vascular about illegally marketing adulterated and misbranded vascular diagnostic ultrasound devices.[ Price : $8.95]
FDA reaffirms support for decentralized clinical trials (DCTs) while making clear that moving trial activities outside traditional...[ Price : $8.95]
FDA commissioner Marty Makary forcefully defends the agency against mounting criticism of recent drug rejections, arguing the agen...[ Price : $8.95]
FDA sends a Warning Letter to CareFusion, citing widespread and repeat violations of current good manufacturing practice regulatio...[ 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New reporting reveals that FDA has withdrawn or blocked the publication of multiple internal studies supporting the safety of Covi...