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Diane Publishing Books
Prescription Drugs: FDA Has Met Most Performance Goals for Reviewing Applications
Marcia G. Crosse (au)
The FDA is responsible for overseeing the safety and efficacy of drugs and biologics sold in the U.S. New drugs and biologics must be reviewed by FDA before they can be marketed. The FDA reviews new drug applications (NDA), biologic license applications (BLA), and efficacy supplements that propose changes to the way approved drugs and biologics are marketed or used. This report: (1) examines trends in FDAäó»s NDA and BLA review performance for FY 2000 through 2010; (2) examines trends in FDAäó»s efficacy supplement review performance for FYs 2000 through 2010; and (3) describes issues that have been raised about the drug and biologic review processes and steps FDA is taking that address them. A print on demand report.
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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