Guidances > Draft Guidance Documents: Good Clinical Practice

Guidances > Draft Guidance Documents: Good Clinical Practice

Three new guidance documents have been added to the page Draft Guidance Documents: Good Clinical Practice

• Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products - Draft Guidance for Industry
• Expanded Access to Investigational Drugs for Treatment Use — Qs & As - Draft Guidance for Industry
• Charging for Investigational Drugs Under an IND — Qs & As - Draft Guidance for Industry

Draft Guidance Documents: Good Clinical Practice

Draft guidance documents have been proposed and are issued for public comment.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.

• More information about draft GCP guidance documents

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Draft Guidance Documents

• Charging for Investigational Drugs Under an IND — Qs & As (PDF - 57KB) -05/2013
• Expanded Access to Investigational Drugs for Treatment Use — Qs & As (PDF - 75KB) -05/2013
• Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products (PDF - 997KB) -12/2012
• IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed (PDF - 62KB) -11/2012
• Electronic Source Data in Clinical Investigations (PDF - 271KB) -11/2012
• Considerations When Transferring Clinical Investigation Oversight to Another IRB -06/2012
• Exculpatory Language in Informed Consent (PDF - 112KB) -08/2011
• Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (PDF - 149KB) -08/2011
• Design Considerations for Pivotal Clinical Investigations for Medical Devices -08/2011
• Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review -08/2011
• In Vitro Companion Diagnostic Devices -07/2011
• Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions -06/2011
• Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND (PDF - 210KB) -10/2010
• IRB Continuing Review After Clinical Investigation Approval - Draft Guidance (PDF - 244KB) -01/2010
• Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions - Draft Guidance (PDF - 34KB) -03/2002