Updates effective as of May 31, 2023

Summary of Policy Updates

Updates effective as of March 14, 2023

Updates effective as of January 3, 2023

Summary of Policy Updates

Updates effective as of September 30, 2022

Summary of Policy Updates

Updates effective as of February 28, 2022

Summary of Policy Updates Note-to-File: Early Implementation of RCO-204 Version 12 UPDATED - FAQ: DF/HCC Policy on Review and Receipt of IND Safety Reports NEW - 9-minute e-Learning on "Investigator Review of External IND Safety Reports"

Updates effective as of September 1, 2021

Review a Summary of Policy Updates

Updates effective as of February 1, 2021

Updates effective as of October 1, 2020

Updates effective as of June 30, 2020

Updates effective as of April 27, 2020

Updates effective as of January 31, 2020

Click here to view a summary of the January 31, 2020 policy updates Click here for a January 2020 Policy Update Training Record Click here for a Guidance/FAQ - 1572 Requirement Change Watch eLearning on 1572 Change & Policy Updates (~12 min)