Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring Committees in ...
The US Food and Drug Administration (FDA) on Tuesday issued final guidance meant to assist drug and medical device makers in developing risk-based monitoring strategies for clinical investigations ...
A major shift in FDA’s current thinking, in comparison with the 2006 guidance, is heightened emphasis in the Agency’s view that DMC assessment of interim safety data alone is not sufficient. FDA ...
Digital health technologies are transforming respiratory medicine, enhancing home monitoring and enabling decentralized clinical trials in resource-limited settings. The Panacea framework evaluates ...
The U.S. Food and Drug Administration has started a pilot program to review clinical trial data in real time, aiming to shorten approval timelines and improve U.S. competitiveness. The program ...
The U.S. Food and Drug Administration (FDA) is moving to speed drug development and review by launching real-time clinical trials. The move could soon mean more options for patients who need ...
Federal regulators have unveiled a pilot program for clinical trials that they say will reduce the time it takes to test drugs. The Food and Drug Administration program will feature real-time clinical ...
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