CDER issues a Manual of Policies and Procedures on establishing drug substance and drug product impurity acceptance criteria for NDAs, ANDAs, and BLAs...
Arca Biopharma submits a special protocol assessment request for its planned Phase 3 clinical development program of Gencaro (bucindolol hydrochloride...
FDA issues a Pharming Group complete response letter on its supplemental BLA for Ruconest [C1 esterase inhibitor (recombinant)] to expand the current ...
AdvaMed gives FDA recommendations for ways to reduce risk in pediatric medical device development.
FDA clears an Olympus 510(k) for its EZ Shot 3 Plus 25 G needle as well as an expanded indication for the EZ Shot 3 Plus product line for both fine ne...
FDA warns ITG-Medev about Quality System violations in its manufacturing of Omiderm wound dressings.
FDA warns Mexicos Jabones Y Productos Especializados about CGMP violations in its production of finished pharmaceuticals.
FDA clears a Meditech Spine 510(k) for its Cure Opel-C Plate System, an add-on technology to its already cleared Cure ACP System and Talos-C (HA) Inte...