2. Intro_FDA_revised_2011_LF_2[1]

2. Intro_FDA_revised_2011_LF_2[1] - An Introduction to the...

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1 An Introduction to the Food and Drug Administration www.fda.gov Laurie Farmer FDA, Atlanta District Office This presentation has been revised by the UGA RA Dept. to reflect recent reorganizational and policy changes at the FDA. Organizational charts in this presentation are for general information purposes only and do not necessarily reflect current FDA reporting structure. For the most up-to-date Organization charts, please visit http://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/default.htm. Objectives To understand FDA’s public health mission To recognize and appreciate the history of the FDA and the products that it regulates Recognize the work of FDA’s program Centers and offices To understand how it carries out its mission of enforcing regulations The most up-to-date FDA organizational charts are located on the FDA website. For purposes of this presentation, Org Charts are place holders: http://www.fda.gov/AboutFDA/CentersOffices/Organizatio nCharts/default.htm 2
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2 Office of Regulatory Affairs (ORA) www.fda.gov/ora/ Training Programs: www.fda.gov/Training/default.htm Lead office for FDA’s field activities Headed by Associate Commissioner for Regulatory Affairs Its mission is … to achieve compliance of regulated products through high-quality, science-based efforts to maximize consumer protection.” www.fda.gov/Training/ForStateLocalTribalRegulators/ default.htm 3 Office of Regulatory Affairs 4
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3 Office Of Regulatory Affairs (ORA) To ensure compliance with public health laws and regulations for: FDA-regulated products Regulated companies Strategies to enforcement include: Sharing and providing information with industry Highlighting of significant violations Targeting high-risk areas Cooperating with state and local public health authorities, Monitoring imported products through both border and foreign inspections 5 Responsibilities of ORA Operate the field offices Manage all field operations Provide advice on regulations and compliance policy matters that impact 3) agency objectives Work with other federal agencies regarding compliance issues and proposed legal actions Conduct criminal investigations coordinating with headquarters and other federal, state, and local law enforcement agencies 6
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ORA Headquarters’ Offices ORA Headquarters is composed of four offices o Office of Resource Management o Office of Regional Operations o Office of Enforcement o Office of Criminal Investigations 7 ORA Field Components ORA’s field offices are organized into five regions. Each is FDA is represented in 49 of the 50 States as well as Puerto Rico and the Virgin Islands. 8
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2. Intro_FDA_revised_2011_LF_2[1] - An Introduction to the...

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