[ Price : $8.95]
FDA issues a Pharming Group complete response letter on its supplemental BLA for Ruconest [C1 esterase inhibitor (recombinant)] to...[ Price : $8.95]
AdvaMed gives FDA recommendations for ways to reduce risk in pediatric medical device development.[ Price : $8.95]
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 l...[ Price : $8.95]
The Clinical Trials Transformation Initiative reports on its public meeting on best practices and needed resources for advancing u...[ Price : $8.95]
FDA publishes a guidance with labeling and safety testing recommendations for heparin-containing medical devices and combination p...[ Price : $8.95]
FDA warns ITG-Medev about Quality System violations in its manufacturing of Omiderm wound dressings.[ Price : $8.95]
FDA warns Mexicos Jabones Y Productos Especializados about CGMP violations in its production of finished pharmaceuticals.[ Price : $8.95]
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 a...