Events

As the race for an effective COVID-19 vaccine continues, the public will get inside look at one a crucial part of the Food and Drug Administration's decisio

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.

“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.

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.

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.

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.

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.