A CDRH webinar suggests questions to consider when determining whether to qualify a proposed medical device development tool.
FDA accepts an Amgen supplemental NDA for Kyprolis (carfilzomib) and dexamethasone that includes overall survival data from the Phase 3 head-to-head E...
FDA clears a Smiths Medical 510(k) for the CADD-Solis ambulatory infusion pump with wireless communication.
FDA warns Indias Hetero Labs about CGMP violations in its manufacturing of finished pharmaceuticals.
FDA says an Acorda Therapeutics NDA for Inbrija is not sufficiently complete to permit a substantive review.
FDA approves a firmware update to Abbott (St. Jude) implantable pacemakers to correct a cybersecurity vulnerability that could lead to patient harm.
Federal Register notice: FDA announces medical device user fee rates and payment procedures for fiscal year 2018.
FDA approves a Boehringer Ingelheim Pharmaceuticals BLA for Cyltezo, a biosimilar version of Abbotts Humira (adalimumab) for multiple inflammatory dis...