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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.
Bridges of Battle: Famous Battlefield Actions at Bridges & River Crossings
Sherlock Holmes Victorian Cookbook: Favourite Recipes of the Great Detective & Dr. Watson
Secret Agenda: One Man’s Fight Against High-Tech Terrorists & Their Biological & Nuclear Weapons of Mass Destruction
Dress Codes: Meanings & Messages in American Culture
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