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Drug Safety: Better Data Management and More Inspections are Needed to Strengthen FDAs Foreign Drug Inspection Program
Drug Safety: Better Data Management and More Inspe

Our Price: $25.00
By Marcia Crosse (au)
Year: 2008
Pages: 58
Binding Paperback

Product Code: 1437911307

The FDA oversees the safety and effectiveness of human drugs marketed in the U.S., including those manufactured in foreign establishments. FDA inspects foreign establishments in order to ensure that the quality of drugs is not jeopardized by poor manufacturing processes. This report examines: (1) the extent to which FDA has accurate data on the number of foreign establishments subject to inspection; (2) the frequency of foreign inspections; and (3) oversight by FDA to ensure that foreign establishments correct serious problems identified during inspections. The author analyzed info. from FDA databases, reviewed inspection reports which identified serious deficiencies, and interviewed FDA officials. Includes recommendations. Illus.

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