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DePuy Synthes recalls certain lots of its Craniomaxillofacial Distraction System because the device may reverse direction and lose...[ Price : $8.95]
Software maker Accelrys describes the regulatory importance of data integrity and audit trails in the U.S. and EU.[ Price : $8.95]
FDA grants Amgen a priority review designation for its NDA for ivabradine for treating chronic heart failure.[ Price : $8.95]
Attorney Shashank Upadhye says drug companies must create a cGMP culture of compliance based on employee training.[ Price : $8.95]
The Maryland federal district court acknowledges that FDA cant order generic makers of Hospiras sedation drug Precedex, subject to...[ Price : $8.95]
Federal Register Notice: FDA corrects a docket number in a Federal Register notice announcing the biosimilar use fee rates for FY ...[ Price : $8.95]
Federal Register Notice: FDA announces the fee rates for using a tropical disease priority review voucher for fiscal year 2015.[ Price : $8.95]
Federal Register Notice: FDA corrects a docket number in a Federal Register notice announcing the FY 2015 fees for human drug comp...