Food and Drug Administration, HHS, Notice, Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability, 85 Fed. Reg. 27987 (May 12, 2020) (Ex. AGY-FED-HEALTH-OTHER-033)
Food and Drug Administration, HHS, 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) (Feb. 29, 2020) (Ex. AGY-FED-HEALTH-OTHER-032)
Food and Drug Administration, HHS, Notice, Revocation of Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability, 86 Fed. Reg. 48712 (Aug. 31, 2021) (Ex. AGY-FED-HEALTH-OTHER-048)
Food and Drug Administration, HHS, Notice, Process for Making Available Guidance Documents Related to Coronavirus Disease 2019, 85 Fed. Reg. 16949 (Mar. 25, 2020) (Ex. AGY-FED-HEALTH-OTHER-131)
Food and Drug Administration, HHS, Notice, Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability, 85 Fed. Reg. 34638 (June 5, 2020) (Ex. AGY-FED-HEALTH-OTHER-034)
Food and Drug Administration, HHS, Notice, Process for Publishing Emergency Use Authorizations for Medical Devices During Coronavirus Disease 2019, 85 Fed. Reg. 33686 (June 2, 2020) (Ex. AGY-FED-HEALTH-OTHER-035)
Food and Drug Administration, HHS (Center for Biologics Evaluation and Research), Emergency Use Authorization letter: Pfizer-BioNTech COVID-19 Vaccine (Dec. 11, 2020; reissued and amended thereafter) (Ex. FED-185)
Food and Drug Administration, HHS, Emergency Use Authorization letter: Moderna COVID-19 Vaccine (Dec. 18, 2020; reissued thereafter) (Ex. FED-186)
Food and Drug Administration, HHS, Emergency Use Authorization letter: Janssen COVID-19 Vaccine (Feb. 27, 2021; reissued thereafter; revoked June 1, 2023) (Ex. FED-187)
