Pandemic Perspectives: COVID’s Unprecedented Experience With Emergency Use Authorizations
The US Food and Drug Administration's EUA pathway has seen more use in the therapeutic and vaccine space during the current pandemic than it has in its entire 16-year history and in many cases the potential eligible populations for the authorized products are far larger than past EUAs. Pink Sheet infographic compares details of past and present EUAs.
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FDA policy experts Jesse Goodman, Mark McClellan, Peter Lurie, David Bowen, Patti Zettler, and Aaron Kesselheim suggest ideas and points to consider in using the COVID-19 experience to assess whether standards for EUAs should be adjusted.
Lumicell’s Cancer Imaging Drug Faces Clinical Meaningfulness, Anaphylaxis Risk Questions At FDA Panel
US FDA advisory committee briefing documents say drug-device combo Lumisight (pegulicianine) is effective at picking up cancer but it is not clear whether that translates to patient benefit.
Despite Marks' relatively upbeat attitude, FDA experts warn that even absent government shutdowns or minimally impactful ones, the current cycle of continuing resolutions and the lingering threat of budget sequestration is harmful to the agency’s operation.