The FDA today announced a new initiative to allow its reviewers to access information from clinical trials in real time, with ...

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

The FDA has launched a pilot program allowing real-time review of clinical trial data, with AstraZeneca and Amgen as the first participants. The initiative aims to speed up drug development by ...

A cancer patient enrolled in a clinical trial today might wait months before regulators ever see the safety data generated by ...

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

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

As climate change accelerates and global temperatures continue to rise, a new randomized clinical trial provides compelling ...

As the use of digital tools continues to expand within clinical research, effective data management for eCOA systems is more important than ever. From initial design and system setup to ongoing ...

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

On April 13, William Blair maintained an Outperform rating on Ocular Therapeutix (NASDAQ:OCUL) right after the presentation ...

Faculty in this hub lead the design, coordination, and analysis of clinical trials for cancer treatment, survivorship, vaccine efficacy, infectious disease prevention and treatment, and cancer ...