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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 1 Regulatory Organization
1-1 - INTRODUCTION
1-2 - OFFICE OF REGULATORY AFFAIRS (ORA)
1-2-1 - Associate Commissioner For Regulatory Affairs (ACRA)
1-2-2 - Office Of Enforcement (HFC-200)
1-2-3 - ORA Field Organization
1-3 - CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)
1-3-1 - Office Of Compliance And Biologics Quality (HFM-600)
1-3-2 - Division Of Case Management (HFM-610)
1-3-3 - Division Of Inspections And Surveillance (HFM-650)
1-3-4 - Division Of Manufacturing And Product Quality (HFM-670)
1-4 - CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
1-4-1 - Office Of Compliance (HFD-300)
1-4-2 - Division Of New Drugs And Labeling Compliance (HFD-310)
1-4-3 - Division Of Manufacturing And Product Quality (HFD-320)
1-4-4 - Division Of Compliance Risk Management And Surveillance (HFD-330)
1-4-5 - Division of Scientific Investigations (HFD-45)
1-5 - CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)
1-5-1 - Office Of Compliance (HFZ-300)
1-5-2 - Division Of Risk Management Operations (HFZ-305)
1-5-3 - Division Of Bioresearch Monitoring (HFZ-310)
1-5-4 - Division Of Enforcement A (HFZ-320)
1-5-5 - Division Of Enforcement B (HFZ-340)
1-5-6 - Office Of Communication, Education And Radiation Programs (HFZ-200)
1-5-7 - Office Of In Vitro Diagnostic Device Evaluation And Safety (HFZ-440)
1-6 - CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN)
1-6-1 - Office Of Compliance (HFS-600)
1-6-2 - Office Of Cosmetics And Colors (OCAC) (HFS-100)
1-6-3 - Office Of Food Safety (HFS-300)
1-6-4 - Office Of Nutritional, Labeling and Dietary Supplements (HFS-800)
1-6-5 - Office of Regulatory Science (HFS-700)
1-7 - CENTER FOR VETERINARY MEDICINE (CVM)
1-8 - ENFORCEMENT POLICY DIRECTORY
1-8-1 - Office Of Regulatory Affairs (ORA) Headquarters
1-8-2 - Office Of Regulatory Affairs (Field)
1-8-3 - FDA Centers
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