FDA Inspection Plans Unclear As EUAs Move Toward Full Approvals

By Kelly Lienhard / January 5, 2021 at 4:10 PM
Industry lawyers say it is unclear how FDA will handle on-site facility inspections as the COVID-19 health emergency spills into 2021 and sponsors of COVID-19 vaccines and therapeutics that received emergency use authorization move toward full approvals. FDA relied largely on facility data provided by industry for its EUA decisions, and the lawyers hear the agency is pondering virtual inspection pilots and other ways to do facility inspections moving forward. It is also unclear how the government would handle already...

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