USA – FDA’s COVID therapeutics, mAbs guidance accounts for variants

As the world rolls into year 2 of the COVID-19 pandemic, regulators and drug developers are grappling with how to address variant strains of SARS-CoV-2 as they bud and expand globally.

The inevitable path for RNA viruses is to mutate, a fact acknowledged by Janet Woodcock, MD, acting commissioner US Food and Drug Administration, in a Monday press conference announcing the availability of new and updated guidance for developers of therapeutics, vaccines, and tests for COVID-19.
 
Collectively, the guidances outline FDA’s vision of a forward-thinking, collaborative and flexible approach to tackle the evolving nature of the pandemic. (RELATED: FDA unveils plans to tackle COVID variantsRegulatory Focus 22 February 2021)
 
“So as long as there is a larger amount of infection going around the world, the probability is that additional virus variants will emerge,” said Woodcock. “We’re going to use every tool in our toolbox to fight the pandemic, including modifications and pivoting as the virus adapts. We want to get ahead of it and we remain committed to getting a product out there even in the face of virus changes.”…