FDA tests real-time clinical-trial reviews to speed approvals
TL;DR
The FDA announced a pilot to let reviewers access safety and efficacy signals from ongoing clinical trials in real time via a cloud platform, with AstraZeneca and Amgen participating, aiming to cut development time and speed regulatory decisions without replacing traditional sponsor meetings. A parallel AI pilot to optimize early trials is planned, and public comments are invited, all while safeguarding patient privacy.
- FDA unveils plan for real-time review of clinical trial data, with AstraZeneca and Amgen already on board Fierce Biotech
- FDA Turns to AI to Speed Up Clinical Trials WSJ
- FDA launches effort to speed up clinical trials, using AI statnews.com
- US FDA to monitor clinical trial data in real time in pilot program aimed at speeding approvals Reuters
- FDA set to pilot test real-time tracking of clinical trials ABC News - Breaking News, Latest News and Videos
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