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Drug Safety : Improvement Needed in FDA's Postmarket Decision-Making and Oversight Process

Drug Safety : Improvement Needed in FDA's Postmarket Decision-Making and Oversight Process

Author: 


ISBN-13: 

9781422307014


ISBN: 

1422307018


Pub Date: 
Publisher:  DIANE Publishing Company
Summary: In 2004, several high-profile drug safety cases raised concerns about the Food & Drug Admin.'s (FDA) ability to manage postmarket drug safety issues. In some cases there have been disagreements within FDA about how to address safety issues. This report: (1) describes FDA's organizational structure & process for postmarket drug safety decision making; (2) assesses the effectiveness of FDA's postmarket drug safety deci...sion-making process; & (3) assesses the steps FDA is taking to improve postmarket drug safety decision making. An organizational review was conducted. In addition, there are case studies of 4 drugs with safety issues: Arava, Baycol, Bextra, & Propulsid. Includes recommendations. Illustrations. [read more]

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Product Details

ISBN-13: 9781422307014


ISBN: 1422307018


Pub Date:
Publisher: DIANE Publishing Company
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