Good Clinical Practice Contacts
- General Information (Good Clinical Practice
Program)
- Biological Products (Bioresearch Monitoring
Branch, CBER)
- Drug Products (Division of Scientific
Investigations, CDER)
- Medical Devices (Division of Bioresearch
Monitoring, CDRH)
- Enforcement Issues (Office of Enforcement,
ORA)
Good Clinical Practice Program (GCPP)
Members of our staff:
- Joanne Less, Ph.D., Director, Good Clinical Practice Program
- Patricia M. Beers Block, Special Assistant to the Director and Expert Consumer
Safety Officer
- Sara Goldkind, M.D., M.A., Senior Bioethicist
- Carolyn Hommel, Expert Consumer Safety Officer
- David A. Lepay, M.D., Ph.D., Senior Advisor for Clinical Science
- Marsha Melvin, Policy Analyst
- Kathleen (Swisher) Pfaender, R.N., J.D., Senior Health Policy Analyst
- Jean Toth-Allen, Ph.D., Biophysicist
Contact the Good Clinical Practice Program if you have:
- general questions about FDA good clinical practice regulations and policy
- general questions about the FDA clinical Bioresearch Monitoring Program,
and specifically clinical investigator, Institutional Review Board (IRB),
sponsor, monitor, and contract research organization programs
- questions about or suggestions related to FDA's
Information Sheets for IRB's and Clinical Investigators
- questions about reports made pursuant to 21 CFR 56.108(b) and 56.113 involving
an FDA-regulated product if you do not know which FDA Center has jurisdiction
(e.g., drug, medical device, biological 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)]
Questions about Good Clinical Practice
Submit questions via email, in writing, or direct them to
our general telephone number. We try to respond to each question as soon as
possible.
(Please note: FDA cannot comment about products that are in the
review process. We cannot comment about clinical trials for specific products,
diseases, or conditions. We cannot answer questions about when a new product
subject to pre-market approval will be approved or not approved.)
E-mail: |
gcp.questions@fda.hhs.gov |
|
Telephone: |
301-827-3340 |
Facsimile: |
301-827-1169 |
Write: |
Food and Drug Administration
Good Clinical Practice Program (HF-34)
Parklawn Building, Room 16-85
5600 Fishers Lane, Rockville, MD 20857 |
Biological Products
Bioresearch Monitoring Branch
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research (CBER)
Telephone: 301-827-6221
Facsimile: 301-827-6748
Contact the Bioresearch Monitoring Branch for questions about:
- The legal status of a test article
- Human subject production regulations relating to biologics
- CBER assigned IRB inspections
- CBER assigned Clinical Investigator inspections
- Reports made pursant 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
Division of Scientific Investigations (DSI)
Office of Compliance
Center for Drug Evaluation and Research (CDER)
Telephone: 301-796-3150
Facsimile: 301-847-8748
Contact DSI: www.fda.gov/cder/Offices/DSI/index.htm
Contact the Division of Scientific Investigations for questions
about:
- Human subject protection regulations pertaining to drugs (21 CFR Parts
50, 56, 312, 361)
- CDER-assigned IRB inspections (e.g., FDA-483's)
- 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
Medical Devices
Division of Bioresearch Monitoring
Office of Compliance
Center for Device and Radiological Health (CDRH)
Phone: 240-276-0125
Fax: 240-276-0128
Web site: www.fda.gov/cdrh/comp/bimo.html
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
- 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 trial
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:
- questions about the overall FDA Bioresearch Monitoring Program, and specifically
the Good Laboratory Practice (GLP, nonclinical laboratories) Program
- general Bioresearch Monitoring program enforcement issues