FDA warns Janssen Vaccines about CGMP violations in its Incheon, South Korea, drug manufacturing facility.
FDA warns Sichuan, China-based Chengdu Brilliant Biopharmaceutical Co. about CGMP deviations in its manufacturing of active pharmaceutical ingredients...
FDA issues Scholar Rock a complete response letter for its BLA seeking approval of apitegromab, indicated for treating spinal muscular atrophy.
FDA publishes a guidance with recommendations for computer software assurance in computers and automated data processing systems in medical device pro...
FDA releases the form FDA-483 with two observations from an inspection at the Genzyme Ireland drug manufacturing facility in Waterford, Ireland.
FDA releases the form FDA-483 with six observations from an inspection at the Cohance Lifesciences drug manufacturing facility in Secunderabad, India.
Sens. Rick Scott and Kirsten Gillibrand ask FDA commissioner Martin Makary to answer 11 questions about the agencys oversight of overseas generic drug...
Olympus recalls (Class 1) its ViziShot 2 FLEX (19G) EBUS-TBNA needles manufactured before 5/12 after receiving reports of device components detaching ...
