The Division of Compliance Risk Management and Surveillance

The Division of Compliance Risk Management and Surveillance identifies, assesses, and prioritizes legal violations based on their public health significance. The division does this by using qualitative and quantitative data analysis and strategic problem solving to target compliance actions which are then used to develop enforcement strategies for reducing public health risks associated with problem drug products. 

The Division of Compliance Risk Management and Surveillance consists of one branch and three teams:

• Risk Management and Strategic Problem Solving Team
• The Surveillance and Data Analysis Branch which consists of 2 teams:
  • Data Analysis and Information Management Team
  • Surveillance Programs Team

What We Do

The Division of Compliance Risk Management and Surveillance serves the American people by:

• Ensuring drug and patient safety by enforcing the Postmarketing Adverse Drug Experience (ADE) Reporting Regulations to ensure timely and accurate submission of ADE reports on adverse drug reactions.
• Supporting CDER’s Office Surveillance and Epidemiology (OSE) with postmarketing drug safety surveillance operations.
• Monitoring the quality of the nation’s drug supply through postmarket surveillance sample collection and analysis, the Drug Quality Reporting System, and Field Alert Reports.
• Identifying less-than-effective drug products in support of the Medicaid Drug Rebate Program.

The Division of Compliance Risk Management and Surveillance supports the following programs and regulations:

• Adverse Drug Experience Reporting
• Drug Product Sampling Surveillance
• Drug Quality Reporting System (DQRS)
• Drug Registration and Listing System (DRLS) and electronic Drug Registration and Listing (eDRLS)
• FDA/Centers for Medicare and Medicaid Services Agreement
• New Drug Application (NDA) Field Alert Reports