FDA posts a draft guidance outlining methods drugmakers should use to collect long-term safety and efficacy data once cell and gene therapy products a...
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...
