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A CDRH official says surveillance and enforcement concerns involving promotional or adverting efforts include unapproved devices, ...[ Price : $8.95]
Teva asks a federal court to order 180-day exclusivity for its Restasis ANDA.[ Price : $8.95]
FDA clears an MC3 510(k) for the Crescent Jugular Dual Lumen Catheter for use in extracorporeal membrane oxygenation.[ Price : $8.95]
FDA commissioner Scott Gottlieb says the agency is seeking international harmonization of generic drug scientific and technical re...[ Price : $8.95]
CDERs Office of Prescription Drug Promotion cautions Eisai about a sales representatives misleading presentation on the safety of ...[ Price : $8.95]
Federal Register notice: FDA classifies the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel into Class 2 ...[ Price : $8.95]
Federal Register notice: FDA determines the patent extension-related regulatory review period for Janssen Biotechs Tremfya (guselk...[ Price : $8.95]
Federal Register notice: FDA debars Isachi Gil for six years from providing services in any capacity to a person that has an appro...