What kind of consistency can industry expect from the FDA post pandemic?
How the US Food and Drug Administration (FDA) exercises flexibility has been an important and emerging issue for the past several years.
The COVID-19 pandemic saw greater flexibility in the regulatory approach to prevent drug shortages.
Some commentators have asked whether the agency’s new experience with and comfort from exercise of its emergency use authorization (EUA) authority during the coronavirus crisis was a factor in the recent accelerated approval of Biogen’s Alzheimer's drug, a move that attracted a significant level of criticism from many quarters.
We talk to Patrick Gallagher, partner at US law firm, Duane Morris, to get his insights and observations on FDA regulatory flexibility. He also discusses what we can expect going forward from the agency, and implications from the fact the US food and drug watchdog still lacks an official commissioner.
