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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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1.  FDA Laws

Federal Food Drug and Cosmetic Act (FFDCA)

2.  Most Relevant 21 CFR Regulations

Part 50      Protection of Human Subjects

Part 56      Institutional Review Boards

Part 312    Investigational New Drug Application

Part 511    New Animal Drugs for Investigational Use

Part 812    Investigational Device Exemptions

3.  Other 21 CFR Regulations 

Part 11       Electronic Records; Electronic Signatures,

Part 54       Financial Disclosure by Clinical Investigators

Part 314     Applications for FDA Approval to Market a New Drug or Antibiotic Drug

Part 514     New Animal Drug Applications

Part 601     Licensing (Applications for FDA Approval of a Biologic License)

Part 814     Premarket Approval of Medical Devices


4.   FDA Guidelines, Guidances, and Inspection Guides

FDA Information Sheet Guidances for Institutional Review Boards and Clinical Investigators (http://www.fda.gov/oc/ohrt/irbs/default.htm)

Guidance for Industry: International Conference on Harmonization (ICH) E6, Good Clinical Practice: Consolidated Guidance (http://www.fda.gov/cder/guidance/959fnl.pdf)

Guidance for Industry: Computerized Systems Used in Clinical Investigations (http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0440-gdl0002.pdf)
Guidance for Industry: Part 11: Electronic Records, Electronic Signatures-- Scope and Application (http://www.fda.gov/ohrms/dockets/98fr/5667fnl.pdf)

Guidance for Industry: Financial Disclosure by Clinical Investigators  (http://www.fda.gov/oc/guidance/financialdis.html)

General Principles of Software Validation; Final Guidance for Industry and FDA Staff (http://www.fda.gov/cdrh/comp/guidance/938.html)

Investigations Operations Manual (IOM), Sections (Filmed or Electronic Records) and (Requesting and Working with Computerized Complaint and Data Failure) (http://www.fda.gov/ICECI/Inspections/InvestigationsOperationsManual/ucm122531.htm)

Draft Guidance for Industry:  Protecting the Rights, Safety, and Welfare of Study Subjects – Supervisory Responsibilities of Investigators (http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0173-gdl0001.pdf)

Guidance for Industry (Guidance 85): Veterinary International Conference on Harmonization (VICH) GL9, Good Clinical Practice, Final Guidance (http://www.fda.gov/cvm/vich.html)

Compliance Policy Guide # 7150.09  Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities  (http://www.fda.gov/ora/compliance_ref/cpg/cpggenl/cpg120-100.html)

Compliance Policy Guide # 7151.02  FDA Access to Results of Quality Assurance Program Audits and Inspections  (http://www.fda.gov/ora/compliance_ref/cpg/cpggenl/cpg130-300.html)

Guidance for Industry and Food and Drug Administration Staff: The Review and
Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program (http://www.fda.gov/cdrh/comp/guidance/1566.pdf)

1.  When medical, technical or scientific questions or issues arise from a specific assignment or if additional information is required about a specific assignment, consult the Center contact identified in the assignment.

2.    For operational questions, contact:

Office of the Associate Commissioner for Regulatory Affairs
Office of Regional Operations (ORO)
Division of Field Investigations: Ruark Lanham, HFC-130
301-827-6691, FAX 301-443-3757

3.  For questions about GCP and Compliance program issues, specific to a Center product area, contact:

Center for Drug Evaluation and Research (CDER)
Division of Scientific Investigations:
Leslie Ball, M.D., HFD-45
301-796-3399, FAX 301-847-8748

Center for Biologics Evaluation and Research (CBER)
Bioresearch Monitoring Staff:
Patricia Holobaugh, HFM-664
301-827-6221, FAX  301-827-6748

Center for Veterinary Medicine (CVM)
Bioresearch Monitoring and Administrative Actions Team:
Vernon Toelle, Ph.D., HFV-234
240-276-9238, FAX 240-276-9241

Center for Devices and Radiological Health (CDRH)
Division of Bioresearch Monitoring:
Donna Headlee, HFZ-310
240-276-0125, FAX 240-276-0128

Center for Food Safety and Applied Nutrition (CFSAN)
Senior Science and Policy Staff:
John Welsh, Ph.D., HFS-205
301-436-1292, FAX 301-436-2972

4.  For crosscutting questions about Good Clinical Practice (GCP)  policy and program issues impacting the Agency's BIMO Programs for GCP, or suggestions to improve this compliance program, contact:

Good Clinical Practice Program
Office of Science and Health Coordination
Office of the Commissioner, HF-34
301-796-8340, FAX 301-827-1169

5.  For information about inspection warrants and final issuance of  Notice of Opportunity of Hearing (NOOH) letters for clinical investigator disqualifications, contact:

Office of Regulatory Affairs
Office of Enforcement (OE)
Director, Division of Compliance Management and Operations (HFC-210)
 240-632-6862,  FAX 240-632-6859