FDA's drug approval process : up to the challenge? : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Ninth Congress, first session, on examining Food and Drug Administration's (FDA) drug approval process, focusing on FDA's drug approval process after a sponsor demonstrates that their benefits outweigh their risks for a specific population and use, and that the drug meet [as printed] meets standards for safety and efficacy, March 1, 2005.