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Drug Safety: Preliminary Findings Suggest Recent FDA Initiatives Have Potential, but do Not Fully Address Weaknesses in its Foreign Drug Inspection Program: Congressional Testimony
Marcia Crosse (au)
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 FDA’s 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 FDA’s initiatives address the weaknesses that have been identified. Illustrations.
Where the Domino Fell: America & Vietnam, 1945 to 1990
Sagas of Icelanders: A Selection
In the Combat Zone: Special Forces Since 1945
Fourth Book of Sexual Questions & Answers
Rudy!: An Investigative Biography of Rudy Giuliani
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