The COVID-19 pandemic has drawn an unusual level of public attention to the daily work processes and operations of the US Food and Drug Administration. But much of the work being spotlighted wasn’t “business as usual.” The agency has worked overtime and used flexibilities afforded it due to the nature of the global public emergency to get experimental products to Americans at record speed – most notably through the emergency use authorization pathway.
Pandemic Perspectives: How COVID Emergency Use Authorizations Could Reshape US FDA
From re-examining the FDA’s place in the broader US government to how fast and flexible it can be clearing therapies in non-emergency times, the COVID-19 EUA experience is expected to have a long-lasting impact on the agency.

More from Approval Standards
A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.
US FDA Commissioner nominee Martin Makary is being embraced by industry, and Senate Democrats, as a more traditional pick than other Trump Administration nominees, but the Make America Healthy Again agenda still is clearly coming to the agency.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Vimkunya, Bavarian Nordic's chikungunya vaccine.
The FDA generic drugs team’s first public workshop of the second Trump Administration ended with a request that industry amplify the value it finds from public engagement.
More from Pathways & Standards
Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.
The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.
A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.