Investigational New Drug (IND) Guidances

The guidances on this page are arranged in order by date, with the most recent guidance added to the top of the list.

Guidance for Industry: CGMP for Phase 1 Investigational Drugs - 7/15/2008

Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs) - 4/9/2008

Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) - 4/9/2008

Draft Guidance for Industry: Pharmacogenomic Data Submissions - Companion Guidance - 8/28/2007

Guidance for Industry: Developing Medical Imaging Drug and Biological Products - 6/17/2004

  • Part 1: Conducting Safety Assessments - (PDF)
  • Part 2: Clinical Indications - (PDF), (Text)
  • Part 3: Design, Analysis, and Interpretation of Clinical Studies - (PDF), (Text)

Draft Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Revision 1) - 1/26/2004 - (PDF), (Text)

Guidance for Industry: IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer (Revision 1) - 1/16/2004 - (PDF), (Text)

Guidance for Industry: Exposure-Response Relationships - Study Design, Data Analysis, and Regulatory Applications - 5/5/2003 - (PDF), (Text)

Guidance for Industry: Special Protocol Assessment - 5/16/2002 - (PDF), (Text)

Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format - Investigational New Drug Applications (INDs) - 3/26/2002 - (PDF), (Text)

Draft Guidance for Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring Committees - 11/15/2001 - (PDF), (Text)

Guidance for Industry: IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing and Controls Information - 5/25/2001 - (PDF)

Guidance for Industry: Financial Disclosure by Clinical Investigators - 3/28/2001 - (Text)

Guidance for Industry: Acceptance of Foreign Clinical Studies - 3/13/2001 - (PDF), (Text)

Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds - 10/26/2000 - (PDF), (Text)

Guidance for Industry: Q & A Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products - 10/3/2000 - (PDF), (Text)

  • Guidance for Industry: Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products - 11/1995 - (PDF)

Guidance for Industry: Formal Dispute Resolution: Appeals Above the Division Level - 3/7/2000 - (PDF)

International Conference on Harmonsation of Technical Requirements for Registration of Pharmaceuticals for Human Use - 2/10/2000 - (PDF)

Guidance for Industry: Submission of Abbreviated Reports and Synopses in Support of Marketing Applications - 9/13/99 - (PDF)

ICH Guidance on the Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing); Availability - 6/25/99 - (PDF), (Text)

Guidance for Industry: Computerized Systems Used in Clinical Trials - 5/10/99 - (Text)

Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review - 11/18/98 - (PDF)
    Appendix 2 (PDF)
    Appendix 3 - CDER MAPP 6020.3 (PDF), CBER SOPP 8405 (Text)
    Appendix 4 (PDF)

ICH Guidance on Statistical Principles for Clinical Trials - 9/16/98 - (PDF), (Text)

ICH Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data - 6/10/98 - (PDF), (Text)

Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products - 5/15/98 - (PDF)

 
Updated: July 23, 2008