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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]
PhRMA calls on FDA to finalize a draft guidance on collecting patient experience data in a timely manner so the guidance may help ...[ Price : $8.95]
FDA approves a new opioid analgesic REMS that now covers immediate-release products and expands provider education requirements.[ Price : $8.95]
CBER says it expects to publish 16 guidances under two categories during calendar year 2018.[ 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...