Janssen COVID-19 Vaccine (299KB) (Reissued June 10, October 20 and November 19, 2021, and May 5, 2022) Federal Register notice, August 29, 2022.More information about the Novavax COVID-19 Vaccineĭecision Memorandum (2.16MB, July 13, 2022)ĭecision Memorandum (1.81MB, August 19, 2022) View the Fact Sheet for Recipients and Caregivers in multiple additional languages.Novavax COVID-19 Vaccine, Adjuvanted (863KB) (Reissued August 19 and September 12, 2022)įor the prevention of Coronavirus Disease 2019 (COVID-19) for individuals 18 years of age and older Most Recent Letter of Authorization (PDF)įact Sheets and Manufacturer Instructions/Package Insert (PDF)Īdditional Information and Decision Memoranda (PDF) Information About COVID-19 EUAs for Medical Devices.Ventilators and Ventilator Accessories EUAs.Remote or Wearable Patient Monitoring Devices EUAs.Decontamination Systems for Personal Protective Equipment EUAs.
Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs.COVID-19 EUAs for Medical Devices, including:.Drugs and Non-Vaccine Biological Products.Detailed Information for all COVID-19 EUAs, including authorizations and fact sheets.Coronavirus Disease (COVID-19) updates from FDA.In addition, in January 2014, FDA issued a question and answer document (PDF, 762K) to respond to questions raised by public health stakeholders about PAHPRA’s amendments to the EUA authority and establishment of new authorities related to the emergency use of MCMs during CBRN emergencies.Ĭoronavirus Disease 2019 (COVID-19) EUA Information For more information, please see the JanuFederal Register notice. In January 2017, FDA finalized the guidance: Emergency Use Authorization of Medical Products and Related Authorities. Information on terminated and revoked EUAs can be found in archived information.
Subsequent HHS declarations supporting use of EUAs and based on this determination are described in the blue boxes below.
On February 4, 2020, the HHS Secretary determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. Please note: a determination under section 319 of the Public Health Service Act that a public health emergency exists, such as the one issued on January 31, 2020, does not enable FDA to issue EUAs. The HHS declaration to support such use must be based on one of four types of determinations of threats or potential threats by the Secretary of HHS, Homeland Security, or Defense. Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives.
0 kommentar(er)
