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Regulatory Procedures Manual
Introduction
Ch. 1 – Regulatory Organization
Ch. 2 – FDA Authority
Ch. 3 – Commissioning and Work Sharing
Ch. 4 – Advisory Actions
Ch. 5 – Administrative Actions
Ch. 6 – Judicial Actions
Ch. 7 – Recall Procedures
Ch. 8 – Emergency Procedures
Ch. 9 – Import Operations And Actions
Ch. 10 – Other Procedures
Ch. 11 – Glossary
Appendix
Chapter Summary
RPM News
Search
Compliance References
Regulatory Procedures Manual 2008
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Chapter 2 FDA Authority
2-1 - THE U.S. FEDERAL JUDICIAL SYSTEM
2-1-1 - U.S. District Courts
2-1-2 - U.S. Circuit Court of Appeals
2-1-3 - The U.S. Supreme Court
2-2 - SELECTED AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
2-2-1 - Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006
2-2-2 - Food Allergen Labeling and Consumer Protection Act of 2004
2-2-3 - Minor Use and Minor Species Animal Health Act of 2004
2-2-4 - Project BioShield Act of 2004
2-2-5 - Pediatric Research Equity Act of 2003
2-2-6 - Animal Drug User Fee Act of 2003 (ADUFA)
2-2-7 - Public Health Security and Bioterrorism Preparedness and Response Act of 2002
2-2-8 - Best Pharmaceuticals for Children Act – 2002
2-2-9 - Medical Device User Fee and Modernization Act of 2002
2-2-10 - FDA Modernization Act of 1997
2-2-11 - Food Quality Protection Act of 1996
2-2-12 - FDA Export Reform and Enhancement Act of 1996
2-2-13 - Dietary Supplement Health and Education Act of 1994
2-2-14 - Animal Medicinal Drug Use Clarification Act of 1994
2-2-15 - Prescription Drug User Fee Act of 1992
2-2-16 - Generic Drug Enforcement Act of 1992
2-2-17 - Medical Device Amendments of 1992
2-2-18 - Safe Medical Devices Act of 1990
2-2-19 - Medical Device Reporting as Amended by The Food and Drug Administration Modernization Act
2-2-20 - Nutrition Labeling and Education Act of 1990
2-2-21 - Electronic Product Radiation Control – 1990
2-2-22 - Anti-Drug Abuse Act of 1988
2-2-23 - Orphan Drug Amendments of 1988
2-2-24 - Prescription Drug Marketing Act of 1987
2-2-25 - Drug Export Amendments Act of 1986
2-2-26 - Health Promotion and Disease Prevention Amendments of 1984
2-2-27 - Drug Price Competition and Patent Term Restoration Act of 1984
2-2-28 - Orphan Drug Act - 1983
2-2-29 - Infant Formula Act of 1980
2-2-30 - Medical Device Amendments of 1976
2-3 - OTHER LAWS
2-3-1 - Public Health Service Act - Biological Products (Part F, Subpart 1)
2-3-2 - Public Health Service Act - Control of Communicable Diseases (Part G)
2-3-3 - Mammography Quality Standards Act of 1992
2-3-4 - Federal Anti-Tampering Act – 1983
2-3-5 - Freedom of Information Act – 1966
2-3-6 - Electronic Freedom of Information Amendments of 1996
2-3-7 - Sanitary Food Transportation Act of 1990
2-3-8 - Pesticides Monitoring Improvements Act of 1988
2-3-9 - AIDS Amendments of 1988
2-3-10 - Lead-Based Paint Poisoning Prevention Act – 1971
2-3-11 - Egg Products Inspection Act - 1970
2-3-12 - Fair Packaging and Labeling Act - 1966
2-3-13 - Federal Import Milk Act
2-3-14 - Health Insurance Portability and Accountability Act of 1996
2-3-15 - Equal Access to Justice Act - 1980
2-3-16 - Sentencing Reform Act of 1984
2-3-17 - Crimes And Criminal Procedure
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