The first-of-its-kind pilot could lead to speedier regulatory approval of medical drugs and devices and potentially reduce ...

Dr. Marty Makary, the FDA’s commissioner, said the program targets “dead time,” or about half the time between the launch of ...

The US Food and Drug Administration (FDA) has announced plans for a future pilot program intended to facilitate the real-time ...

The U.S. FDA announced on Tuesday that Amgen (AMGN) and AstraZeneca (AZN) have initiated real-time clinical trials as the agency seeks to launch a pilot program designed to accelerate drug development ...

Most people associate time trials with a session between prelims and finals during a championship meet, but time trials can also be conducted as a stand-alone event. A common denominator of time ...

Three recommendations for response-side standards before the pilot is scaled ...

The FDA’s real-time clinical trial mechanism allows drug sponsors to transmit data immediately to the regulator through the ...