FDA Gives Extra Time for Drug Study Feedback: Yawn.
Published Date: 3/13/2025
Notice
Summary
The FDA is giving everyone more time to share their thoughts on the draft rules for good clinical practice in drug studies, called E6(R3) Annex 2. This affects drug companies and researchers who want to make sure their studies meet the latest safety and quality standards. Comments are now open until March 31, 2025, so get your feedback in before the final rules are set—no extra costs, just your voice!
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Comment Period Extended to March 31, 2025
The FDA reopened the public comment period for the draft guidance "E6(R3) Good Clinical Practice: Annex 2" so interested persons may submit comments through March 31, 2025. The original deadline had been February 28, 2025; submit comments to Docket No. FDA-2024-D-5601 via https://www.regulations.gov or by mail to Dockets Management Staff.
Guidance Targets Decentralized Trials and Real-World Data
The draft guidance provides Good Clinical Practice considerations specifically for trial design and conduct that include decentralized and pragmatic elements and for trials that utilize real-world data. Annex 2 is intended to be read and implemented with the E6(R3) Principles and Annex 1.
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