Center BIMO Program Contacts
- Biological Products (Bioresearch Monitoring Branch, Center for Biologics Evaluation and Research)
- Drug Products (Office of Scientific Investigations, Center for Drug Evaluation and Research)
- Enforcement Information (Office of Enforcement, Office of Regulatory Affairs)
- Food or other products regulated by the Center for Food Safety and Applied Nutrition (Bioresearch Monitoring Program, Office of the Director, CFSAN)
- Medical Devices (Division of Bioresearch Monitoring, Center for Devices and Radiological Health)
- New Animal Drugs (Premarket Compliance and Administrative Actions Team, Center for Veterinary Medicine)
Biological Products
Bioresearch Monitoring Branch
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research (CBER)
Telephone: 240-402-8010
Facsimile: 301-595-1245
Email: ocod@fda.hhs.gov
Contact the Bioresearch Monitoring Branch for questions about:
- The legal status of a test article
- Human subject protection regulations related to biologics
- CBER assigned IRB inspections
- CBER assigned clinical investigator inspections
- Reports made pursuant to 21 CFR 56.108(b) and 56.113 involving a biologic product including:
- unanticipated problems involving risks to subjects
- serious or continuing noncompliance by an investigator with FDA regulations or with the IRB's determinations
- suspension or termination of IRB approval of a protocol
Drug Products
Office of Scientific Investigations (OSI)
Office of Compliance
Center for Drug Evaluation and Research (CDER)
Telephone: 301-796-3150
Facsimile: 301-847-8748
Email: CDER-OSI-GCPReferrals@fda.hhs.gov
Contact the Office of Scientific Investigations for questions about:
- Human subject protection regulations pertaining to drugs (21 CFR Parts 50, 56, 312, 320, 361)
- CDER-assigned IRB inspections
- Reports made pursuant to 21 CFR 56.108(b) and 56.113 involving a drug product including:
- unanticipated problems involving risks to subjects [21 CFR 56.108(b)(1)]
- serious or continuing noncompliance by an investigator with FDA regulations or with the IRB's determinations [21 CFR 56.108 (b)(2)]
- suspension or termination of IRB approval of a protocol [21 CFR 56.108(b)(3)]
- Reporting complaints related to human subject protection/good clinical practice in FDA-regulated drug trials
Enforcement Information
Division of Compliance Policy
Office of Enforcement
Office of Regulatory Affairs
Telephone: 240-632-6800
Fax: 240-632-6810
Contact the Division of Compliance Policy for questions about:
- FDA’s Bioresearch Monitoring Program, Compliance Programs, and the Good Laboratory Practice (GLP) Program for nonclinical laboratories
- Bioresearch Monitoring Program enforcement issues
Food or other products regulated by the Center for Food Safety and Applied Nutrition
Bioresearch Monitoring Program
Office of Center Director
Center for Food Safety and Applied Nutrition (CFSAN)
Phone: 240-402-1757
Fax: 301-436-2668
Contact the Bioresearch Monitoring Program for questions about:
- Human subject protection related to studies involving foods or other CFSAN-regulated products
- CFSAN-regulated products include:
- food additives
- color additives
- infant formula
- dietary supplements
- Human subject protection related to petitions for nutrient content claims and health claims
- Reporting complaints related to the conduct of clinical trials of CFSAN-regulated products
Medical Devices
Division of Bioresearch Monitoring
Office of Compliance
Center for Device and Radiological Health (CDRH)
Phone: 301-796-5490
Fax: 301-847-8136
Website: Bioresearch Monitoring
Contact the Division of Bioresearch Monitoring for questions about:
- Human subject protection regulations pertaining to devices [21 CFR Parts 50, 56, and 812]
- Informed consent, standard operating procedures, records and reports in clinical trials for medical devices
- Serious or continuing noncompliance by an investigator with FDA regulations or with the IRB's determinations involving a medical device [21 CFR 56.108(b)(2)]
- Reporting complaints related to human subject protection/good clinical practice in FDA-regulated medical device trials
New Animal Drugs
Premarket Compliance and Administrative Action Team
Center for Veterinary Medicine (CVM)
Phone: 240-276-9200
Fax: 240-276-9241
Contact the Premarket Compliance and Administrative Actions Team for questions about:
- Good clinical practice regulations related to new animal drugs for investigational use (21 CFR Part 511)
- Reporting complaints related to the conduct of studies with new animal drugs for investigational use