Information Sheet Guidances
Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors

Table of Contents

General

• Frequently Asked Questions (1998)
• Cooperative Research (1998)
• Non-local IRB Review (1998)
• Continuing Review After Study Approval (1998)
• Sponsor - Investigator - IRB Interrelationship (1998)
• Foreign Clinical Studies, Acceptance of (2001)
• Charging for Investigational Products (1998)
• Recruiting Study Subjects (1998)
• Payment to Research Subjects (1998)
• Screening Tests Prior to Study Enrollment (1998)
• Informed Consent, A Guide To (1998)
• Use of Investigational Products When Subjects Enter a Second Institution (1998)
• Coverage of Personal Importations (2001)
• Exception from Informed Consent for Studies Conducted in Emergency Settings: Regulatory Language and Excerpts from Preamble (1998)
• "Off-Label" and Investigational Use of Marketed Drugs, Biologics and Medical Devices (1998)
• Data Retention when Subjects Withdraw (2008)

Drugs and Biologics

• Emergency Use of an Investigational Drug or Biologic (1998)
• Treatment Use of Investigational Drugs (1998)
• Waiver of IRB Requirements for Drug and Biological Product Studies (2006)
• Drug Study Designs (1998)
• Evaluation of Gender Differences (1998)

Medical Devices

• Frequently Asked Questions about IRB Review of Medical Devices (2006)
• Significant Risk and Nonsignificant Risk Medical Device Studies (2006)

FDA Operations

• FDA Institutional Review Board Inspections (2006)
• FDA Inspections of Clinical Investigators (2006)
• Clinical Investigator Regulatory Sanctions (1998)

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