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 of Drug Safety (ODS) 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:
