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    Usfda Usfda Presentation Transcript

    • The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics.
    • The Office of the Commissioner (OC) The Center for Drug Evaluation and Research (CDER) The Center for Biologics Evaluation and Research (CBER) The Center for Food Safety and Applied Nutrition (CFSAN) The Center for Devices and Radiological Health (CDRH) The Center for Veterinary Medicine (CVM) The National Center for Toxicological Research (NCTR) The Office of Regulatory Affairs (ORA) The Office of Criminal Investigations (OCI) FDA Organizations
    • FDA regulates Cosme tics Drugs Foods Medical Devices Radiation emitting electronic products Veteri nary produ cts Biologics
    • Landmarks In Regulations Food and Drug Act 1906 Federal Food, Drug and Cosmetic Act 1938 Durham- Humphrey Amendments 1951 Hatch-Waxman Act 1984 Comprehensive Drug Abuse Prevention and Control Act 1970 Prescription Drug User Fee Act 1992 Drug Safety Board 2005 Kefauver-Harris Drug Amendments 1962 Hatch-Waxman Act 1984
    •  Acts as consumer watchdog in America’s healthcare system.  Oversees the research, development, manufacture and marketing of drugs.  Ensures safety and efficacy of available drugs.  Regulates:  Prescription drugs  Generic drugs  OTC drugs  Also ensures truth in advertising for prescription drugs.
    • Center For Food Security and Applied Nutrition
    • Radiation Ionizing X-ray e.g. Dental radiography, Industrial X-ray etc. Optical (visible, UV,IR,laser ) e.g. Surgical laser, Germicide lamp etc. RF, Microwave, magnetic e.g. MRI, Microwave oven etc. Acoustic (ultrasonic) e.g.Ultrasonography, Hearing aids etc.
    • Regulates food, food additives, and drugs that are given to animals(food animals, pets) Primary focus – 1.on medications that are used in food animals, and 2. assurance that they don’t affect human food supply Restricts the spread of bovine spongiform encephalopathy by doing inspections of feed manufacturers
    • National Center for toxicological Research(NCTR) Research arm of FDA The research at NCTR supports FDA’s goals: 1) to understand critical biological events in the expression of toxicity, 2) to develop and characterize methods, and incorporate new technologies to improve the assessment of human exposure, susceptibility, and risk, and 3) to increase the understanding of the interaction between genetics, metabolism, and nutrition.
    • ORA mission is to enhance public health by implementing FDA regulations and minimizing the risks associated with the products Office Of Regulatory Affairs
    • FDA’s Office of Criminal Investigations (OCI) is an integral part of FDA’s mission to protect the public’s health. Top-flight special agents –who have investigative authority similar to other federal law enforcement agencies – give the FDA unique fact-finding tools and provide for strong, industry-wide deterrence. Their work is different from, but enhances, the regulatory inspectors and investigators that make up the bulk of FDA’s field operations. -