FDA Office of Privacy information specialist Elizabeth Booker Houstons recent departure goes viral after dramatically announcing her resignation with ...
Some fired FDA employees say they received sensitive information about other employees in addition to their own.
FDA warns Henderson, NV-based Private Label Grooming about CGMP violations in its production of over-the-counter drugs.
FDA warns Port Huron, MI-based Spectra Therapy about Quality System, Medical Device Reporting, and Unique Identifier violations in its production of a...
Novartis says its experimental antibody ianalumab, when combined with eltrombopag, significantly extended the time to treatment failure in patients wi...
Draeger recalls (Class 1) its SafeStar and TwinStar breathing filters due to a risk of misleading carbon dioxide readings.
AI expert Brooke Moy says FDA may have felt pressured to move too quickly to implement its Elsa internal AI tool without planning for sufficient human...
FDA approves an Insmed NDA for Brinsupri (brensocatib) tablets as the first treatment for non-cystic fibrosis bronchiectasis in patients aged 12 and o...
