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U.S. Department of Health and Human Services

About FDA

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Office of Compliance Program Description

CDER Office of Compliance’s mission is to promote and protect public health through strategies and actions that minimize consumer exposure to unsafe, ineffective, and poor quality drugs.

The Office of Compliance consists of four offices, the Office of Manufacturing and Product Quality (OMPQ); Office of Scientific Investigations (OSI); Office of Drug Security, Integrity, and Recalls (ODSIR); and Office of Unapproved Drugs and Labeling Compliance (OUDLC).
 

This rotation will allow the student to become familiar with the role of FDA in drug development, review, manufacturing, supply chain security, and labeling compliance. Specifically, students will learn about the Federal Food, Drug, and Cosmetic Act and how the Office of Compliance addresses issues such as oversight of drug compliance programs; monitoring of drug quality though inspections; advising stake holders on regulatory and enforcement issues; Center-Field coordination; interpretation of standards; policy development; recall coordination; monitoring of drug shortages; and threats to the global drug supply chain.