Researchers say that nearly one-third of adverse event reports submitted to the FDA MAUDE medical device database came in later than allowed by regula...
The Senate Health Education Labor and Pensions Committee votes to advance the nomination of Marty Makary as FDA commissioner.
FDA warns staff returning to offices on 3/17 that they can face parking and workspace issues, Reuters reports.
FDA clears a Canon Medical 510(k) for artificial intelligence enhancements for the Aquilion One/Insight Edition CT scanner.
Amgen says it will file a BLA supplement by 6/30 for Uplizna (inebilizumab-cdon) to expand its use to treat adults living with generalized myasthenia ...
Two Akin Gump attorneys discuss a new FDA Web page with information on medical device data integrity.
FDA cautions Indias Chemspec Chemicals about a CGMP deviation in its production of active pharmaceutical ingredients.
FDA says manufacturers are recalling seven acne products containing benzoyl peroxide to the retail level after testing found possible benzene contamin...
