FDA cites Biocon Biologics for a series of manufacturing and quality control deficiencies following an inspection of the companys drug substance manuf...
FDA clears a BD 510(k) for its EnCor EnCompass Breast Biopsy and Tissue Removal System, a new platform designed to allow clinicians to perform breast ...
Reuters reports exclusively that FDA medical reviewers have slowed reviews on two drugs in the new Commissioners National Priority Voucher Program due...
Jazz Pharmaceuticals sells its FDA Priority Review Voucher for $200 million to an undisclosed purchaser.
FDA clears an iotaMotion 510(k) for an expanded pediatric indication for its iotaSOFT robotic-assisted cochlear implant insertion system.
Charles River Laboratories names former FDA principal deputy commissioner Namandj N. Bumpus as senior vice president and chief scientific and innovati...
Taxpayers Protection Alliance executive director Ross Marchand says FDA needs to change its risk-averse approach to drug evaluation and accelerate app...
FDA warns Winder, GA-based Winder Laboratories about repeat CGMP violations in its manufacturing of finished drugs.
