- References
- FFDCA - Sections 501(i), 505(i) and 505(k)(2)
- Regulations in 21 CFR Parts 11, 50, 56, 312, 314, 511, 514, 809, 812, and 814.
- SPECIFIC FORMS
- FDA Form 1571 - Investigational New Drug Application (See 21 CFR 312.40)
- FDA Form 1572 - Statement of Investigator, (See 21 CFR 312.53(c))
- Notice of claimed investigational exemption for a new animal drug, (See 21 CFR
511.1(b)(4)).
- ICH Good Clinical Practice Consolidated Guideline, May 1997.
- Guideline for the Monitoring of Clinical Investigations, January 1988.
- Good Target Animal Study Practices: Clinical Investigators and Monitors, May 1997.
- Program Contacts
When technical questions arise on a specific assignment, or when additional information
or guidance is required, contact the assigning Center. Operational questions should be
addressed to HFC-130.
- Office of the Associate Commissioner for Regulatory Affairs
- Office of Enforcement, Division of Compliance Policy: Dr. James F. McCormack, HFC-230,
301-827-0425, FAX 301-827-0482.
- Office of Regional Operations, Division of Emergency and Investigational Operations: Dr.
Thaddeus Sze, HFC-130, 301-827-5649, FAX 301-443-6919.
- Center for Drug Evaluation and Research (CDER), Division of Scientific Investigations:
- Good Clinical Practice Branch I Dr. John Martin, HFD-46, 301-594-1032, FAX
301-827-5290.
- Good Clinical Practice Branch II Dr. Antoine El Hage, HFD-47, 301-594-1032, FAX
301-827-5290.
- Center for Biologics Evaluation and Research (CBER)
Division of Inspections and Surviellance Mr. Joseph Salewski, HFM- 664,
301-827-6221, FAX 301-827-6748.
- Center for Veterinary Medicine (CVM)
Bioresearch Monitoring Staff: Ms. Dorothy Pocurull, HFV-234, 301-827-6664, FAX
301-827-1498.
- Center for Devices and Radiological Health (CDRH)
Division of Bioresearch Monitoring: Ms. Barbara Crowl, HFZ-311, 301-594-4720, FAX
301-594-4731.
- Center for Food Safety and Applied Nutrition (CFSAN)
Division of Product Policy: Dr. John Welsh, HFS-207, 202-418-3057, FAX 202-418-3126.
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