WHO WE ARE:
The Office of Testing and Research operates as an integrated testing and research FDA laboratory to develop scientific methods and tools to assess pharmaceutical quality issues and support the following core functions: standard, guidance, and policy development, pharmaceutical quality surveillance, quality assessment of regulatory submissions, and rapid response to public health emergencies.
WHAT WE DO:
- Conducts laboratory research on manufacturing, formulation, and characterization of drugs that supports quality review, inspection, quality standard and policy development, education, and rapid response activities.
- Directs drug quality surveillance testing and laboratory-based investigational activities for the Center as needed for public health emergencies.
- Provides advice/consults, collaborative research opportunities, and scientific training for FDA staff on pharmaceutical quality, pharmaceutical equivalence, and bioavailability/bioequivalence issues including manufacturing, formulation, analytical testing, and modeling.
- Participates in an integrated quality assessment team in the Office of Pharmaceutical Quality in needed areas.
- Coordinates with other Agency components to educate the public on Center and Agency policy and activities.
- Participates in Center-level committees to coordinate research priorities with other Center for Drug Evaluation and Research (CDER) offices.
- Directs and coordinates with relevant FDA Offices to meet Generic User Fee Amendments science and research priorities and requirements.
- Supports a lifecycle approach to drug application approval by providing relevant expertise and laboratory data to aid quality assessment of supplements and abbreviated new drug applications.
- Coordinates extramural research through contracts or grants and administers extramural research activities for Office of Pharmaceutical Quality in needed areas.
- Works with relevant FDA offices to plan and direct CDER-relevant Office of Regulatory Affairs laboratory activities.
The Office of Testing and Research has locations in White Oak, MD and St. Louis, MO and is comprised of three divisions:
- Division of Product Quality Research (DPQR)
- Division of Pharmaceutical Analysis (DPA)
- Division of Complex Drug Analysis (DCDA)
Director: Dr. David Keire, Acting
Resources For You:
- Office of Pharmaceutical Quality
- Emerging Technology Program
- OPQ Annual Report, 2019
- Report on the State of Pharmaceutical Quality, 2019 (PDF - 793KB)
- Pharmaceutical Quality Resources
- White Paper: FDA Pharmaceutical Quality Oversight (PDF - 2.4MB)