FDA Information Sheets
- 21 CFR Part 50 - Protection of Human Subjects
- 21 CFR Part 56 - Institutional Review Boards
- Letter Re: Information Sheets, February 1999
- Frequently Asked Questions
- Cooperative Research
- Non-Local IRB Review
- Information Sheet
- Sponsor-Investigator-IRB Interrelationship
- Acceptance of Foreign Clinical Studies
- Charging for Investigational Products
- Recruiting Study Subjects
- Payment to Research Subjects
- Screening Tests Prior to Study Enrollment
- A Guide to Informed Consent
- Use of Investigational Products when Subjects Enter a Second Institution
- Exception from Informed Consent for Studies Conducted in Emergency Settings Regulatory Language and Excerpts from Preamble
- "Off-Label" and Investigational Use of Marketed Drugs, Biologics, and Medical Devices
- Drugs and Biologics
- Medical Devices Guidance: Significant Risk and Non-Significant Risk Devices
- Selected Reference Material for Placebo Control Trials
