News

The US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee plans to meet on 22 October to discuss matters related to authorization and licensure of vaccines for COVID-19. No application will be on the docket at…

“Clinical trials are critical” in the battle against the global COVID-19 pandemic, Amy Abernathy, principal deputy commissioner and acting CIO of the U.S. Food and Drug Administration (FDA), told attendees of the Veeva R&D and Quality Summit on…

I’m delighted to be with you today for this important meeting of the Global Coalition for Regulatory Science Research.  I only wish that we could be together in person. I want to thank Bill Slikker and his co-chair of the Scientific Program…

The Reagan-Udall Foundation for the FDA, with input from experts at FDA, has introduced an Expanded Access eRequest app to streamline expanded access for individual patients in non-emergency settings. “Time is critical when patients have a serious or…

Dr. William Morice of Mayo Clinic Laboratories shares insights on real-world evidence (RWE) and its role in advancing COVID-19 diagnostics in this Aetion 'Ask the Accelerators' feature.

When a patient is in need of an important medicine, paperwork and forms are the last thing their physician wants to deal with. In some cases, it’s necessary, but the U.S. Food and Drug Administration is doing everything we can to keep it to a minimum.…

On February 4, 2020, the U.S. secretary of health and human services declared that emergency use of diagnostics for SARS-CoV-2 was justified, triggering emergency authority for the Food and Drug Administration (FDA) to grant an emergency use…

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. Aetion, the New York health tech startup, has for the second time…

The U. S. Food and Drug Administration has been proactive and supportive of test development by all comers — including laboratories, and large and small commercial manufacturers — to speed development and to quickly authorize tests that the science…