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FDA denies a petition seeking a partial exemption of 510(k) requirements for some specific radiology computer-aided detection and/...[ Price : $8.95]
Two bipartisan senators press FDA to take a more proactive role in policing prescription drug advertising, citing a surge in misle...[ Price : $8.95]
Ultragenyx Pharmaceutical refiles a BLA seeking accelerated approval for UX111, an AAV9 gene therapy for the treatment of Sanfilip...[ Price : $8.95]
In a wide-ranging 4/1 address to employees at FDA, commissioner Marty Makary outlines an expansive agenda to accelerate drug appro...[ Price : $8.95]
FDA grants full approval for Kites CAR-T cell therapy Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or ref...[ Price : $8.95]
A rare disease coalition calls on the Trump administration to appoint a new CBER director who understands rare disease drug develo...[ Price : $8.95]
An FDA untitled letter cautions the Fort Myers, FL-based LeeSar drug outsourcing facility about CGMP and other violations in its p...[ Price : $8.95]
FDA warns Clifton, NJ-based Physitemp Instruments about Quality System, Medical Device Reporting, Unapproved Device, and Unique De...