Eua

What kind of consistency can industry expect from the FDA post pandemic?

22-Jul-2021 By Jane Byrne

How the US Food and Drug Administration (FDA) exercises flexibility has been an important and emerging issue for the past several years.

J&J submits EUA application for single-shot COVID-19 vaccine

08-Feb-2021 By Rachel Arthur

J&J pledges to start shipping doses of its COVID-19 vaccine in the US as soon as Emergency Use Authorization (EUA) is received from the Food and Drug Administration, while it plans to apply for Conditional Marketing Authorization in the EU in the...

FDA authorizes Moderna COVID-19 vaccine for emergency use in the US

19-Dec-2020 By Jane Byrne

The US Food and Drug Administration (FDA) has authorized emergency use of Moderna’s vaccine against COVID-19, mRNA-1273, in individuals who are 18 years of age or older.

Pfizer and BioNTech COVID-19 vaccine authorized for use in the UK

02-Dec-2020 By Jane Byrne

The Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK has granted a temporary authorization for emergency use for Pfizer and BioNTech's mRNA vaccine (BNT162b2), against COVID-19.