Join our mailing list!
(Your shopping cart is empty)
Diane Publishing Books
Drug Safety: Improvement Needed in FDA’s Postmarket Decision-Making and Oversight Process
Marcia Crosse (au)
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 decision-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.
Asia Rising: Why America Will Prosper as Asia’s Economies Boom
Politician Goes to War: The Civil War Letters of John White Geary
Politics of Despair: Power & Resistance in the Tobacco Wars
Around the American Table: Treasured Recipes & Food Traditions from the American Cookery Collections of the New York Public Library
Gates of the Alamo
Share your knowledge of this product with other customers...
Be the first to write a review
Diane Publishing Co
PO Box 617
Darby, PA 19023-0617
Become an Affiliate
Send Us Feedback
Copyright ï¿½ 2004 Diane Publishing Company. All Rights Reserved.