FDA clears a Fujifilm Healthcare Americas 510(k) for its new compact, 128-slice computed tomography (CT) system, the FCT iStream.
Public Citizen recommends three steps FDA should take to improve the public perception and understanding of the work of agency advisory committees.
FDA publishes a table with information on 14 drug submissions in FY 2023 that contained real-world evidence.
FDA warns Cartersville, GA-based Sani-Care Salon Products about CGMP violations in its work as a contract manufacturer of finished drugs.
FDA warns the Carmel, IN-based Indiana Lions Eye Bank about deviations from the regulations for human cells, tissues, and cellular and tissue-based pr...
CDER Office of New Drugs Special Program Staff associate director Yoni Tyberg discusses the New Drug Regulatory Program modernization and its successe...
Advanced Medical Technology Association says there are inconsistencies and ongoing concerns with FDAs guidance on remanufacturing/servicing medical de...
Regeneron calls on FDA to develop two guidances to further the use of precision medicine in non-oncology diseases.
