Globalisation has placed increasing demands on the FDA in ensuring the safety and effectiveness of drugs marketed in the United States. Drugs manufactured in more than 100 countries were offered for entry into the U.S. in fiscal year 2009. The FDA inspects manufacturing establishments in order to ensure that the safety and quality of drugs are not jeopardised by poor manufacturing practices. This book examines the issues and impacts of foreign pharmaceuticals, including more foreign drug inspections by the FDA; and improving the FDAs information and oversight on foreign drug establishments.
Preface; Drug Safety:: FDA Has Conducted More Foreign Inspections & Begun to Improve Its Information on Foreign Establishments, but More Progress is Needed; Potential Health & Safety Impacts from Pharmaceuticals & Supplements Containing Chinese-Sourced Raw Ingredients; The Emergence of Indias Pharmaceutical Industry & Implications for the U.S. Generic Drug Market; Index.
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