The Food and Drug Administration (FDA) is reopening the comment period for the draft guidance titled "E6(R3) Good Clinical Practice: Annex 2," originally announced on December 30, 2024. This guidance provides updated recommendations on clinical trial design and conduct, especially those involving digital elements and real-world data. The reopening is intended to give people more time to submit comments by March 31, 2025, before the final version is prepared. The FDA made this decision following requests for extra time to develop more comprehensive feedback.
Simple Explanation
The FDA wants to give people more time to share their thoughts on new rules for running medical tests that might use gadgets and real-world data. They've reopened the period when people can send in their ideas until the end of March 2025.