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  1. Clinical Trials and Human Subject Protection

Withdrawn or Expired Clinical Trial Guidance Documents

This table lists clinical trial guidance documents that have been withdrawn and no longer represent FDA’s current thinking. These documents are presented for historical purposes only.

Title Issue
Date		 Withdrawal
Date
"Off-Label" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices January 1998 April 2024
IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects July 2017 December 2023
Clinical Investigator Regulatory Sanctions - Information Sheet January 1998 October 2023
Charging for Investigational Products: Guidance for Institutional Review Boards and Clinical Investigators January 1998 October 2023
Drug Study Designs: Guidance for Institutional Review Boards and Clinical Investigators January 1998 October 2023
Treatment Use of Investigational Drugs: Guidance for Institutional Review Boards and Clinical Investigators January 1998 October 2023

 

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