Who We Are
The Office of Scientific Investigations (OSI) ensures that CDER-regulated drugs, biologics, and biosimilars have reliable evidence of safety and effectiveness, and meet postmarket safety requirements. OSI also protects the rights, safety, and welfare of human subjects in clinical trials. In collaboration with the Office of Study Integrity and Surviellance, OSI administers FDA’s bioresearch monitoring (BIMO) compliance programs.
What We Do
- Ensure the validity of clinical trial data submitted to FDA in support of applications to demonstrate the safety and efficacy, or bioequivalence, of drugs for human use.
- Protect the rights and welfare of human research subjects enrolled in clinical studies.
- Ensure investigators, sponsors, and contract research organizations conducting nonclinical and clinical studies on investigational new drugs comply with applicable federal laws and regulations covering good clinical practice and good laboratory practice.
- Direct inspections of institutional review boards (IRBs) and radioactive drug research committees (RDRCs) for compliance with standards and regulations designed to protect the rights and welfare of human research subjects.
- Monitor sponsors and manufacturers for compliance with risk evaluation and mitigation strategies, postmarket adverse drug experiences, and safety labeling commitments.
- Work to bring inspected entities with significant violations of federal laws and regulations into compliance through warning letters and other actions.
- Division of Clinical Compliance Evaluation
- Division of Enforcement and Postmarketing Safety
Office of Compliance
10903 New Hampshire Avenue
Bldg. 51, Room 5271
Silver Spring, MD 20993-0002