FDA publishes a guidance with labeling and safety testing recommendations for heparin-containing medical devices and combination products.
PhRMA calls on FDA to finalize a draft guidance on collecting patient experience data in a timely manner so the guidance may help drug sponsors.
FDA approves a new opioid analgesic REMS that now covers immediate-release products and expands provider education requirements.
CBER says it expects to publish 16 guidances under two categories during calendar year 2018.
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...
Federal Register notice: FDA establishes a public docket to collect comments related to the post-marketing, pediatric-focused safety reviews of produc...