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    Fda Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices and Biologies
    by Author: Douglas J. Pisano
    Editor: David Mantus

    Binding: Paperback, 328 pages
    Publisher: CRC Pr Llc
    Published Date: 12/01/2003
    List Price: USD $169.95
    Weight: 1.15 pounds
    1587160072
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        Publisher's Note:
    the drug approval process, Current Good Manufacturing Practices, Good Clinical Practices, Quality System Compliance and the corresponding documentation requirements, and FDA inspection processes and enforcement options. Although many references exist on this subject, this one is written in a general prose style that makes it useful to both students and professionals.


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