Could you provide an overview of what happened in 2020 due to covid and speculate what the lasting impact will be in 2021. Will there be a continued impact of COVID on FDA resources and submission timelines?

2020 was a rough year for FDA with submissions and reviewers because they have been slammed with EUA requests and the extra product load that was very unexpected because of COVID-19. However, if you look at the MDUFA report, they have been meeting a lot of their goals.



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