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    3. FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, 2nd Edition (Repost)

    FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, 2nd Edition (Repost)

    Posted By: nebulae
    Date: 7 Feb 2017 14:14:16
    FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, 2nd Edition (Repost)

    Douglas J. Pisano, David S. Mantus, "FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, 2nd Edition "
    2008 | ISBN-10: 1420073540 | 464 pages | PDF | 8 MB

    Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.

    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

    Three all-new chapters cover:

    clinical trial exemptions
    advisory committees
    provisions for fast track
    UPWARDS