| Ex. AGY-FED-HEALTH-OTHER-033 | Notice, Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability, 85 Fed. Reg. 27987 (May 12, 2020)Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability | Food and Drug Administration, HHS | United States (federal); Food and Drug AdministrationFederal | May 12, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Health care ordersSupply chainOther | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-032 | Policy for Diagnostics Testing in Laboratories Certified To Perform High Complexity Testing Under CLIA Prior to Emergency Use Authorization for Coronavirus Disease-2019 During the Public Health Emergency; Immediately in Effect Guidance, 85 Fed. Reg. 13138 (Mar. 6, 2020)Policy for Diagnostics Testing in Laboratories Certified To Perform High Complexity Testing Under the Clinical Laboratory Improvement… | Food and Drug Administration, HHS | United States (federal); Food and Drug AdministrationFederal | Feb. 29, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Health care ordersOther | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-131 | Notice, Process for Making Available Guidance Documents Related to Coronavirus Disease 2019, 85 Fed. Reg. 16949 (Mar. 25, 2020)Process for Making Available Guidance Documents Related to Coronavirus Disease 2019 | Food and Drug Administration, HHS | United States (federal); Food and Drug AdministrationFederal | Mar. 25, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Other | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-034 | Notice, Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability, 85 Fed. Reg. 34638 (June 5, 2020)Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability | Food and Drug Administration, HHS | United States (federal); Food and Drug AdministrationFederal | June 5, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Health care ordersSupply chain | Primary source read | |
| Ex. AGY-FED-HEALTH-OTHER-035 | Notice, Process for Publishing Emergency Use Authorizations for Medical Devices During Coronavirus Disease 2019, 85 Fed. Reg. 33686 (June 2, 2020)Process for Publishing Emergency Use Authorizations for Medical Devices During Coronavirus Disease 2019 | Food and Drug Administration, HHS | United States (federal); Food and Drug AdministrationFederal | June 2, 2020 | 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3 | Other | Primary source read | |
| Ex. FED-185 | Emergency Use Authorization letter: Pfizer-BioNTech COVID-19 Vaccine (Dec. 11, 2020; reissued and amended thereafter)Letter of Authorization, Pfizer-BioNTech COVID-19 Vaccine | Food and Drug Administration, HHS (Center for Biologics Evaluation and Research) | United StatesFederal | Dec. 11, 2020 | 2020 Q42021 Q12021 Q22021 Q3 | Health care ordersOther | Primary source read | |
| Ex. FED-186 | Emergency Use Authorization letter: Moderna COVID-19 Vaccine (Dec. 18, 2020; reissued thereafter)Letter of Authorization, Moderna COVID-19 Vaccine | Food and Drug Administration, HHS | United StatesFederal | Dec. 18, 2020 | 2020 Q42021 Q12021 Q22021 Q3 | Health care ordersOther | Primary source read | |