Mission: To promote and protect public health through strategies and actions that minimize consumer exposure to unsafe, ineffective, and poor quality drugs.
Vision: Through excellence in risk- and science-based policy, surveillance, and enforcement, we prevent consumer exposure to unnecessary risk from drugs throughout their lifecycle.
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. We do this by:
- Addressing public health risks associated with legal violations.
- Developing and overseeing drug compliance programs designed to reduce consumer exposure to risks of unsafe and ineffective drugs.
- Monitoring the quality of human drugs through inspectional coverage, product testing, and other pre- and post-market surveillance activities.
- Advising the Center Director and other Agency officials on regulatory and enforcement issues involving human drugs.
- Coordinating Center-Field relations and providing support and guidance to field offices on case development and regulatory actions.
- Ensuring uniform interpretation of standards.
- Developing policies and compliance strategies to ensure that over-the-counter and prescription drugs are of high quality, properly labeled, safe, pure, and meet applicable drug approval requirements.
- Developing policy and standards to achieve high product quality through application of current good manufacturing practice requirements. We accomplish this by coordinating surveillance and pre-approval inspections.
- Coordinating evaluation and classification of drug recalls and working with field offices for implementation of recalls.
- Monitoring resolution of drug shortage situations involving compliance issues.
- Implementing programs and projects to identify, assess, and prioritize the public health significance of legal violations.
- Developing and using innovative enforcement strategies to reduce public health risks associated with legal violations.
As CDER stands up the new Office of Pharmaceutical Quality
in January, 2015, the Office of Compliance will also standup a partially restructured organization as follows:
Director: Cynthia Schnedar
Deputies: Ilisa Bernstein and Michael Levy
- Office of Drug Integrity, Security, and Response (ODSIR): Thomas J. (TJ) Christl
- Office of Manufacturing Quality (OMQ): Thomas Cosgrove
- Office of Program and Regulatory Operations (OPRO): Collin Figueroa (acting)
- Office of Scientific Investigations (OSI): Sean Kassim
- Office of Unapproved Drugs and Labeling Compliance (OUDLC): Kalah Auchincloss (acting)
CDER Comment Form
Office of Compliance
10903 New Hampshire Avenue
Bldg. 51, Rm 5271
Silver Spring, MD 20993-0002
Phone: (301) 796-3100
Fax: (301) 847-8747