FDA clears a DePuy Synthes 510(k) for the Viper and Expedium Fenestrated Screw Systems.
CDERs Gisa Perez says the GDUFA agreement pending before Congress contains three financial provisions intended to address concerns of small businesses...
FDA clears a Gramercy Extremity Orthopedics (GEO) 510(k) for the GEO Bone Screw System, which can be used for bone fractures, osteotomies, arthrodesis...
An Advera Health evidence review says that Genentechs Kadcyla and Perjeta have multiple unlabeled adverse events that appear on its Herceptin label.
An FDA-funded study demonstrates the ability of prospective, active surveillance of a representative clinical registry to identify potential safety si...
The CDER Office of Pharmaceutical Quality issues a MAPP to help product quality microbiology reviewers locate needed information in applications filed...
Attorney Kurt Karst says the overworked FDA Office of Orphan Product Development received 582 requests for orphan drug designations in 2016 and approv...
Hospira recalls one lot of vancomycin hydrochloride for injection due to a confirmed customer report of particulate matter within a single vial.