FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics - No cost Library

FDA regulatory affairs: a guide for prescription drugs, medical devices, and biologics

   Author(s): Douglas J. Pisano, David S. Mantus  

        Publisher: Informa Healthcare USA, Year: 2008   

                                        

 Description: 

FDA Regulatory Affairs: provides a blueprint to the FDA and drug, biologic, and medical device development offers current, real-time information in a simple and concise format contains a chapter highlighting the new drug application (NDA) process discusses FDA inspection processes and enforcement options includes contributions from experts at companies such as Millennium and Genzyme, leading CRO’s such as PAREXEL and the Biologics Consulting Group, and the FDA

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