Events

Submitting expanded access requests to FDA just got easier for physicians.

On February 4, 2020, the U.S.

Dr. Nirosha Lederer discusses COVID-19’s impact on the future of real-world evidence (RWE), key learnings, and evolving regulatory perspectives in this Aetion 'Ask the Accelerators' interview.

Former FDA chief Scott Gottlieb’s favorite real-world evidence platform is getting a new stream of cash, as it nears what will likely be the biggest test of the young company so far.

The following quote is attributed to Harpreet Singh, M.D., Associate Director, Cancer in Older Adults and Special Populations, FDA’s Oncology Center of Excellence; and Director, Division of Oncology 2, FDA’s Center for Dru

The U. S.

Traditionally, the healthcare industry has moved slowly when embracing new technology innovations.

The FDA will participate in the Covid-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project organized by the Reagan-Udall Foundation for the FDA in collaboration with Frien

At a Medical Device Innovation Consortium fireside chat Thursday, FDA Commissioner Stephen Hahn said the agency will take a fresh look at how it regulates diagnostics and digital technologies after the coronavirus pandemic

FDA is upping efforts to incorporate real-world data in evaluation of COVID-19 diagnostics and antibody tests, announcing Thursday participation in a partnership exploring how to use that data to improve testing