Office of Bioresearch Monitoring Operations (OBIMO)
The Office of Bioresearch Monitoring Operations (OBIMO), within the Office of Regulatory Affairs (ORA), is responsible for conducting inspections of clinical and nonclinical research conducted in support of marketing applications for FDA regulated products across all centers.
BIMO inspections focus on:
- Ensuring the protection of trial participants involved in clinical research
- Studies are conducted according to applicable regulations
- The reliability of data submitted in applications to FDA
The BIMO program includes Postmarketing Adverse Drug Experience (PADE) and Risk Evaluation and Mitigation Strategies (REMS) inspections as part of the portfolio.
OBIMO's highly skilled, collaborative, and agile workforce ensures research subjects are protected and the data used to support FDA decisions is reliable.
What We Do
- Domestic and foreign inspections of regulated entities conducting clinical and nonclinical research
- Inspections of drug establishments for compliance with PADE and REMS requirements
- Training and outreach to industry and academia
- Collaboration with international regulatory partners
Who We Are
Report a Problem
Vaccine Adverse Effects Reporting System
MedWatch: The FDA Safety Information and Adverse Event Reporting Program
Clinical Trials Complaints
Reporting Complaints Related to FDA-Regulated Clinical Trials
- FDA Sponsor-Investigator Virtual Conference - 03/07/2023 - 03/09/2023
- FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Conference - 03/21/2023 - 03/22/2023
- FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Conference - 06/13/2023 - 03/15/2023