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Book Synopsis
The Food and Drug Administration Safety and Innovation Act (FDASIA), amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the authority of the Food and Drug Administration (FDA) in performing its human drug, biological product, and medical device responsibilities. Frequently referred to as the user fee reauthorisation act, FDASIA does include four titles relating to user fees. This book focuses on these acts, as well as the prescription drug user fee act, the FDA medical device user fee program and discusses the proposed FDA user fee acts generic drug user fee amendments.

Food & Drug Administration Safety & Innovation

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A Hardback by James C Perry

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    View other formats and editions of Food & Drug Administration Safety & Innovation by James C Perry

    Publisher: Nova Science Publishers Inc
    Publication Date: 01/02/2014
    ISBN13: 9781629487748, 978-1629487748
    ISBN10: 1629487740
    Also in:
    Manufacturing industries Food security and supply

    Description

    Book Synopsis
    The Food and Drug Administration Safety and Innovation Act (FDASIA), amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the authority of the Food and Drug Administration (FDA) in performing its human drug, biological product, and medical device responsibilities. Frequently referred to as the user fee reauthorisation act, FDASIA does include four titles relating to user fees. This book focuses on these acts, as well as the prescription drug user fee act, the FDA medical device user fee program and discusses the proposed FDA user fee acts generic drug user fee amendments.

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