Compliance Activities (Drugs)
The Office of Compliance advances CDER’s mission of assuring that safe and effective drugs are available to the American people by protecting Americans from unsafe, ineffective and poor quality drugs.
Office of Compliance Organization
- CDER’s Office of Compliance webpage and organization information
- Division of New Drugs and Labeling Compliance
- Division of Manufacturing and Product Quality
- Division of Compliance Risk Management and Surveillance
- Division of Scientific Investigations
- Contact Information
Documents and Information
- Warning Letters
- Current Good Manufacturing Practices (cGMPs)
- Inspection Guides
- Manufacturing Standards
- Industry Guidances
Compliance Activities
- Adverse Drug Experience Reporting
- Bioresearch Monitoring Program (BIMO)
- Drug Product Sampling Surveillance
- Drug Quality Reporting System (DQRS)
- Drug Registration and Listing System (DRLS) and electronic Drug Registration and Listing (eDRLS)
- New Drug Application (NDA) Field Alert Reports
- Drug Recalls
- Importing and Exporting of Human Drugs and Biologics
Training Courses