A CDRH Webinar explains provisions in a recent guidance on the appropriate use of voluntary consensus standards in premarket submissions.
Sandoz decides not to pursue FDA approval for its proposed biosimilar of rituximab (Genentechs Rituxan), indicated for treating some non-Hodgkins lymp...
FDA issues Lupin a five-item Form 483 after an inspection at the firms Madhya Pradesh, India manufacturing plant cited significant GMP violations.
FDA clears a NinePoint Medical 510(k) to market its Intelligent Real-time Image Segmentation software upgrade for its NvisionVLE Imaging System.
Federal Register notice: FDA makes available a guidance entitled Unique Device Identification: Policy Regarding Compliance Dates for Class I and Uncla...
Federal Register notice: FDA submits to OMB an information collection extension for Biosimilars User Fee Program.
A joint FDA panel meeting votes 17 to 1 that data support the benefit-risk profile of Sages Zulresso (brexanolone) injection for treating postpartum d...
FDA clears a Shoulder Innovations 510(k) for the InSet Humeral Short Stem System for partial or total shoulder arthroplasty used in the treatment of d...