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  1. Center for Drug Evaluation and Research | CDER

CDER OPQ Centers of Excellence

The Office of Pharmaceutical Quality (OPQ) stood up as a super office within the Center for Drug Evaluation and Research (CDER) in January 2015. This CDER super office has established itself as a global leader in regulatory science and research pertaining to drug product quality. It is critical to the mission of CDER to ensure that regulatory science and research remains the foundation that underlies sound regulatory decisions. To achieve this goal, OPQ established research Centers of Excellence (COE). The purpose of the COE is to provide a platform for  centralized, focused, research collaboration and communication—across the FDA and externally to the American Public and pharmaceutical industry stakeholders—in scientific areas in which OPQ excels. 

COE Scientific Areas:

  • Immunology
  • Infectious Diseases and Inflammation
  • Manufacturing Science and Innovation (small and biological molecules)
  • Pharmaceutical Analysis and Characterization
  • Tumor Biology

COE Roles:

  • Promote OPQ's culture and capabilities
  • Advance internal and external scientific collaborations
  • Facilitate research communication, coordination and project indentification/selection

More Information:


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