Draft guidance documents have been proposed and are issued for public comment. Each FDA draft document lists how to submit comments to the agency.
The entries below are listed in reverse chronological order by publication date.
Draft Guidance Documents
- Institutional Review Board (IRB) Written Procedures – Draft Guidance for Institutions and IRBs (PDF - 163KB) -08/2016
Minutes of Institutional Review Board (IRB) Meetings - Draft Guidance for Institutions and IRBs-11/2015
- Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States (PDF - 649KB) -04/2015
Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND(PDF - 305KB) -09/2013
Informed Consent Information Sheet-07/2014
- Humanitarian Device Exemption (HDE): Questions and Answers -03/2014
Charging for Investigational Drugs Under an IND — Qs & As(PDF - 87KB) -06/2016
Expanded Access to Investigational Drugs for Treatment Use — Qs & As(PDF - 180KB) -06/2016
Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products(PDF - 997KB) -12/2012
- Exculpatory Language in Informed Consent (PDF - 112KB) -08/2011
- Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions -11/2013