1. Introduction_FDA_Aug2011_DWM_2[1]

1. Introduction_FDA_Aug2011_DWM_2[1] - An Introduction to...

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1 An Introduction to the Food and Drug Administration David W. Mullis, Jr., Ph.D., RAC, Director UGA BioPharma Regulatory Affairs Graduate Education Program Email: [email protected] This presentation has been revised by the UGA RA Dept. to reflect recent reorganizational changes at the FDA. Objectives To understand FDA’s public health mission To review the Agency’s organization Provide an Overview of FDA’s program Centers and Offices To understand how FDA carries out its mission of enforcing regulations FDA organizational charts are located on the FDA website (Check frequently…Things are constantly changing!) 2
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2 What is FDA? A part of the U.S. Department of Health and Human Services of the Federal Government It is a Law Enforcement Agency and a regulatory agency 1997 - The FDA Modernization Act (FDAMA) reaffirmed FDA’s mission to protect public health. Specifically, its mission is to “Promote public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.” 3 Current mission statement The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. (From http://www.fda.gov/AboutFDA/WhatWeDo/default.htm) Food and Drug Administration Modernization Act (FADAMA) of 1997:http://www.fda.gov/RegulatoryInformation/Legislation/Feder alFoodDrugandCosmeticActFDCAct/SignificantAmendmentstoth eFDCAct/FDAMA/default.htm 4
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This note was uploaded on 01/01/2012 for the course PHAR 6010 taught by Professor Mullis during the Spring '11 term at UGA.

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1. Introduction_FDA_Aug2011_DWM_2[1] - An Introduction to...

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