Food and Drug Administration's (FDA) authority to monitor drug labeling practices. Topics include the preemption of state laws by the FDA, federal labeling requirements, and the regulation of medical devices. Information is provided on medical company compliance with FDA regulations.Valoir...
Companies want quicker turnaround from FDA. The article focuses on the aim of pharmaceutical, biotechnology and medical device companies to gain faster turnaround times and other improvements from th... J.,G.,D. - 《Medical Marketing & Media》 被引量: 0发表: 2007年 Combination Printing Opens...
Background The Riata class of defibrillator leads were placed under US Food and Drug Association (FDA) advisory as of November 2011 because of high rates o... Emily,P.,Zeitler,... - 《Heart Rhythm》 被引量: 7发表: 2015年 A scan-specific quality control acquisition for clinical whole-bod...
Senator Ted Kennedy's objection to a provision in the FDA overhaul bill requiring the agency to grant market clearance to medical device manufacturers.EBSCO_AspHuman Events
Food and Drug Administration (FDA) of a new labeling for the Sapien Transcatheter Heart Valve of heart valves and hemodynamic monitoring manufacturer Edwards Lifesciences in the third week of September 2013. The new labeling allows the device to be used by an expanded group of patients who have...
Food and Drug Administration (FDA) for the In-Vivo Optical Spectroscopy (IBVOS) system of Somanetics. According to the company, the labeling will allow a claim of improved patient outcomes after surgery when the technology is used to manage therapies in patients above 2.5 kilograms at risk for...
If successful, the results of the trial will be submitted to the FDA to obtain an indication for the treatment of permanent AF in patients requiring concomitant open heart surgery.JohnsonHollandEBSCO_AspMedical Device Daily
Food and Drug Administration (FDA) to BioCheck on December 7, 2010 for making promotional claims on its labels and in product inserts for several biological reagents. The move is reportedly an indication of the agency's adoption of stricter review of product labels. A similar letter issued to...