Who We Are
The Office of Scientific Investigations (OSI) ensures that CDER-regulated drugs and biologics have reliable evidence of safety and effectiveness and meet postmarket safety requirements. OSI also ensures the rights, safety and welfare of individuals participating in clinical trials are protected. In collaboration with CDER’s Office of Study Integrity and Surveillance, OSI administers FDA’s Bioresearch Monitoring compliance programs for CDER.
OSI Annual Report FY 2022 (PDF - 1 MB)
What We Do
- Ensure that investigators, sponsors and contract research organizations conducting nonclinical and clinical studies on investigational new drugs comply with regulations covering good clinical practice, bioavailability and bioequivalence, and good laboratory practice.
- Ensure the validity of clinical trial data submitted to FDA in support of applications to demonstrate the safety and efficacy of drugs for human use.
- Direct inspections of institutional review boards and radioactive drug research committees for compliance with regulations designed to protect the rights and welfare of individuals participating in clinical trials.
- Evaluate sponsors’ compliance with risk evaluation and mitigation strategies, postmarket adverse drug experience reports and postmarket study requirements.
- Evaluate and take appropriate actions on complaints about clinical investigators, sponsors, monitors, institutional review boards and contract research organizations.
- Work to bring inspected entities with significant violations of federal laws and regulations into compliance through warning letters and other administrative actions.
- Monitor compliance with ClinicalTrials.gov registration and results information submission requirements and initiate compliance and enforcement actions when necessary.
- Develop and implement regulations, guidance and regulatory strategies to advance the conduct of clinical and nonclinical research and postmarket safety activities, and collaborate with foreign regulatory counterparts.
- 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
For complaints and required reports related to the conduct of clinical trials please contact: CDER-OSI-GCPReferrals@fda.hhs.gov.