The FDA is responsible for overseeing the safety and effectiveness of human drugs that are marketed in the U.S., whether they are manufactured in foreign or domestic estab. FDA inspects foreign estab. to ensure that they meet the same standards required of domestic estab. Ongoing concerns regarding FDAAis foreign drug inspection program recently were heightened when FDA learned that contaminated doses of a common blood thinner had been manufactured at a Chinese estab. that the agency had never inspected. FDA has announced initiatives to improve its foreign drug inspection program. This statement presents preliminary findings on how FDAAis initiatives address the weaknesses that have been identified. Illustrations.Congressional Testimony Marcia Crosse. officials expect that this number will increase, 23 they expect that the elimination of establishments that do not manufacture medical devices for the U.S. marketaand thus should not be registeredawillanbsp;...
|Title||:||Drug Safety: Preliminary Findings Suggest Recent FDA Initiatives Have Potential, But Do Not Fully Address Weaknesses in Its Foreign Drug Inspection Program|
|Publisher||:||DIANE Publishing - 2009-01|