Investigational Drugs

• Access to Investigational Drugs: Questions and Answers
  National Cancer Institute
• Frequently Asked Questions on Drug Development and Investigational New Drug Applications
  U.S. Food and Drug Administration
• Investigational Drugs
  Developmental Therapeutics Program, National Cancer Institute
• Investigational New Drug (IND) Application Process
  U.S. Food and Drug Administration

• IRB Guidebook Office for Human Research Protections
  U.S. Department of Health and Human Services
• Office for Human Research Protections
  U.S. Department of Health and Human Services
• Office of Research Integrity
  U.S. Department of Health and Human Services
• Books
  • Kornetsky, Susan; Applied Research Ethics National Association.
    Study Guide for Institutional Review Board : Management and Function
    Sudbury, Mass. : Jones and Bartlett, c2003
  • Dawson, John; Foley, Mary; Peart, Nicola
    Research Ethics Commmittees
    In: Law of Research : a guide
    Dunedin, N.Z. : University of Otago Press, 2003.
  • Bankert, Elizabeth A; Amdur, Robert J; Amdur, Robert J
    Institutional Rreview Board : Management and Function, 2nd ed.
    Sudbury, Mass. : Jones and Bartlett, c2006.
  • ECRI
    Institutional Review Boards : Regulatory and Risk Management Overview
    In: Healthcare Risk Control V. 2, Risk Analysis
    Plymouth Meeting, Pa. : ECRI, c2005.

• Rozovsky, F.A.; Adams, Rodney K
  Clinical Trials and Human Research : A practical guide to regulatory compliance, 1st ed.
  San Francisco : Jossey-Bass, 2003
• Code of Federal Regulations
  • Title 21--Food and Drugs
    Chapter I--Food and Drug Administration
    Department of Health and Human Services
    Subchapter A--General Part 50 Protection of Human Subjects
  • Title 45 -- Public Welfare
    Department of Health and Human Services
    Part 46
    Protection Of Human Subjects
  • 21 CFR Part 210 [Docket No. FDA-2005-N-0170] (formerly Docket No. 2005N-0285)
    Food and Drug Administration, HHS.
    Direct final rule.
    Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials(PDF, 65 KB)
    Federal Register / Vol. 71, No. 10 / Tuesday, January 17, 2006 / Rules and Regulations
  • 21 CFR Part 312, [Docket No. 2000N–1663], RIN 0910–AA61
    Food and Drug Administration, HHS.
    Direct final rule
    Investigational New Drugs: Export Requirements for Unapproved New Drug Products
    Federal Register: November 23, 2005 (Volume 70, Number 225) / Rules and Regulations / Page 70720-70730
  • 21 CFR Parts 201, 314, and 601, [Docket No. 2000N–1269] (formerly Docket No. 00N–1269), RIN 0910–AA94
    Food and Drug Administration
    Final Rule
    Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products
    Federal Register: January 24, 2006 (Volume 71, Number 15 /Rules and Regulations / Page 3921-3997
• Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
  U.S. Food and Drug Administration
• Guidances / Guidelines / Points to Consider
  U.S. Food and Drug Administration
• HIPAA Privacy Rule and Its Impacts on Research
  National Institutes of Health
• Regulations and Ethical Guidelines
• Office for Human Research Protections (OHRP) Policy Guidance
  U.S. Department of Health and Human Services
• Quick Reference Guide
  Developmental Therapeutics Program
  National Cancer Institute

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