Please follow https://www.fda.gov/regulatory-information/search-fda-guidance-documents/effects-covid-19-public-health-emergency-formal-meetings-and-user-fee-applications-questions-and.

Please follow https://www.fda.gov/regulatory-information/search-fda-guidance-documents/effects-covid-19-public-health-emergency-formal-meetings-and-user-fee-applications-questions-and.