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.
Accelerated Approval, Real World Evidence Pilot From ICER, Aetion Picks HAE As First Therapeutic Area
ICER signals how it will pick other therapies for pilot in interview with Pink Sheet. Aetion believes project will help 'pressure test' the RWE field and show health plans and providers the value of using real world evidence to supplement clinical trial data.
Pink Sheet reporters and editor discuss the influence of the emergency use authorization on FDA decisions, another twist in the march-in rights debate, and how CBER is not using the real-time oncology review program.