[20080908]RS22946_食品和药物管理局（FDA）：概述和问题.pdf

Order Code RS22946September 8, 2008Food and Drug Administration (FDA):Overview and IssuesErin D. WilliamsSpecialist in Public Health and BioethicsDomestic Social Policy DivisionSummaryThe Food and Drug Administration (FDA) is the agency within the Department ofHealth and Human Services (HHS) that regulates human and animal drugs, medicaldevices, biologics, and most foods. This report describes FDA, surveys agency-relatedissues Congress faces, and cites CRS reports where readers can find more information.FDA Overview FDA is an agency within HHS that regulates a wide range of products valued at morethan $1 trillion. (See Table 1.) The agency is responsible for the safety of most foods(human and animal) and cosmetics, and it regulates both the safety and the effectivenessof human drugs, biologics (e.g., vaccines, blood and blood components), medical devices,and animal drugs. In many cases, its responsibilities abut those of other agencies. (SeeTable 1.) In such cases, interagency agreements may define the regulatory boundaries.The primary law authorizing FDA activities is the Federal Food, Drug, and CosmeticAct (FFDCA; 21 USC Chapter 9). (See Table 2.) FDA is also responsible forimple