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Mission, Organization, and Operations Presentation by Gray Etheredge and Cathy Chang

Mission, Organization, and Operations Presentation by Gray Etheredge and Cathy Chang January 20, 2004. What does the ORA do? The ORA protects the public health by coordinating all FDA inspections and regulatory activities. Laws Enforced by the FDA and Related Statutes.

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Mission, Organization, and Operations Presentation by Gray Etheredge and Cathy Chang

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  1. Mission, Organization, and Operations Presentation by Gray Etheredge and Cathy Chang January 20, 2004

  2. What does the ORA do? The ORA protects the public health by coordinating all FDA inspections and regulatory activities.

  3. Laws Enforced by the FDA and Related Statutes • Federal Food, Drug, and Cosmetic Act • 1997 Modernization Act • Administrative Procedures Act • Animal Drug User Fee Act of 2003 • Best Pharmaceuticals for Children Act • Bioterrorism Act of 2002 • Congressional Reports Elimination Act of 1982 • Controlled Substances Act • Controlled Substances Import and Export Act • Delegations of Authority to the Commissioner of Food and Drugs • Department of Education Organization Act • Dietary Supplement Health and Education Act of 1994 • Egg Products Inspection Act • Fair Packaging and Labeling Act • Federal Advisory Committee Act • Federal Advisory Committee Amendments • Federal Anti-Tampering Act • Federal Food and Drugs Act of 1906 • Federal Fines and Sentencing Laws • Federal Import Milk Act • Federal Meat Inspections Act • Filled Milk Act • Food Quality Protection Act of 1996 • Federal Trade Commission Act • Foods and Drugs • GATT Uruguay Round Patent Provisions • Generic Animal Drug and Patent Term Restoration Act of 1988 (Summary) • Government in the Sunshine Act • Laws Delegating Authority -- Patents • Lead Based Paint Poisoning Prevention Act • Mammography Quality Standards Act (MQSA) • Medical Device User Fee and Modernization Act (MDUFMA) of 2002 • Miscellaneous Provisions Relating to Orphan Drugs • Pediatric Research Equity Act of 2003 • Poultry Products Inspection Act • Prescription Drug User Fee Act • Public Health Service Act • Reorganization Plan 1 of 1953 • Sanitary Food Transportation Act • Sentencing Guidelines • Tea Importation Act The Tea Importation Act was repealed in 1996 by Public Law 104-128 • Trademark Act of 1946

  4. Office of Regulatory Affairs • Central Office Which Oversees the Operation of the ORA • Office of Resource Management • Organizes and Allocates Manpower and Management and Financial Data • Office of Enforcement • Monitor and Evaluates Compliance Activities, Pursue Legal Issues • Office of Regional Operations • Develops Proposal and Instructions Affecting Field Activities • Office of Criminal Investigations • Implements Agency Polices Related To Criminal Investigations • Regional Field Offices • Carries Out Field Operation: Inspections, Education, and Business Relations

  5. Links To ORA Sites • Compliance Refs. • FDA/ORA Compliance References Contents Inspection Refs. FDA/ORA Inspection References Science Refs. Science References Portal Page

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