Federal drug officials are aiming to significantly reduce the timeline for new drug development by launching real-time ...
The first-of-its-kind pilot could lead to speedier regulatory approval of medical drugs and devices and potentially reduce “20, 30, 40% of overall clinical trial time,” according to FDA Chief ...
AI in clinical trials holds great promise for the entire drug development lifecycle. However, any new technology should ...
While digital health technologies (DHTs) offer potential new ways to collect data in clinical trials, industry stakeholders ...
Why does it take a new drug 10 years, on average, to come to market? Part of the reason lies in the dead time in the process. Historically, trials have required tedious tabulations and repeated ...
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 ...
More flexibility in early-phase development for cell therapies is needed, a panel of US Food and Drug Administration (FDA) ...
Under the new leadership of Marty Makary, the FDA should focus more attention on the critical role of real-world clinical data — such as from health insurance databases — in the ongoing assessment of ...
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