Office of Pharmaceutical Quality Research
Who We Are
The Office of Pharmaceutical Quality Research (OPQR), part of CDER’s super Office of Pharmaceutical Quality, protects the public health by assuring the quality and availability of drugs and biologics by conducting mission-relevant research that addresses current and future needs to support:
- Science- and risk-based quality assessments of regulatory submissions
- Standard, guidance, and policy development
- Pharmaceutical quality surveillance, and
- Rapid responses to public health issues
What We Do
- Conducts laboratory research that supports quality assessment, inspection, quality standard and policy development, education, surveillance, and rapid response activities.
- Performs drug quality surveillance testing and laboratory-based investigational activities to support The Office of Pharmaceutical Quality (OPQ) and the Center as needed for public health emergencies and to generate data to inform decision making.
- Provides advice/consults, collaborative research opportunities and scientific training for The Food and Drug Administration’s (FDA) staff on pharmaceutical quality, comparability/biosimilarity/interchangeability, pharmaceutical equivalence, and bioavailability/bioequivalence issues includes manufacturing, formulation, analytical testing, and modeling.
- Participates in relevant quality assessment and policy development activities.
- Support OPQ laboratory science needs including coordination of extramural research through contracts or grants and administers extramural research activities for OPQ.
Office Organization
- Division of Pharmaceutical Quality Research I
- Division of Pharmaceutical Quality Research II
- Division of Pharmaceutical Quality Research III
- Division of Pharmaceutical Quality Research IV
- Division of Pharmaceutical Quality Research V
- Division of Pharmaceutical Quality Research VI
Resources
- Office of Pharmaceutical Quality
- Pharmaceutical Quality Resources
- Office of Pharmaceutical Quality Reports