U.S. Food and Drug Administration

which of the following statements is true of biological therapies?

Español

Có thể bạn quan tâm

About Emergency Use Authorizations (EUAs)

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies.

Bạn đang xem: U.S. Food and Drug Administration

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. 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.

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. 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. Subsequent HHS declarations supporting use of EUAs and based on this determination are described in the blue boxes below.

Information on terminated and revoked EUAs can be found in archived information.

Coronavirus Disease 2019 (COVID-19) EUA Information

FDA expects the COVID-19 public health emergency (PHE) declared by the Department of Health and Human Services under the Public Health Service Act to expire on May 11, 2023. The ending of the COVID-19 PHE will not impact FDA’s ability to authorize medical countermeasures for emergency use. Existing COVID-19 EUAs will remain in effect, and the agency may continue to issue new EUAs if the situation meets the criteria to do so. Read more about what happens to EUAs when a public health emergency ends.

Coronavirus Disease (COVID-19) updates from FDA
Detailed Information for all COVID-19 EUAs, including authorizations and fact sheets
- COVID-19 EUAs for Vaccines
- COVID-19 EUA for Convalescent Plasma
- COVID-19 EUAs for Drugs and Non-Vaccine Biological Products
- COVID-19 EUAs for Medical Devices, including:
  - Blood Purification Devices EUAs
  - Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs
  - In Vitro Diagnostics EUAs
  - Decontamination Systems for Personal Protective Equipment EUAs
  - Infusion Pump EUAs
  - Personal Protective Equipment EUAs
  - Remote or Wearable Patient Monitoring Devices EUAs
  - Respiratory Assist Devices EUAs
  - Ventilators and Ventilator Accessories EUAs
  - Other Medical Device EUAs
- Information About COVID-19 EUAs for Medical Devices

Note: In the table below, the Additional Information column contains links to information including fact sheets, EUA letters of authorization, regulatory information, decision memos, health care provider information, and Federal Register notices.

Xem thêm : How Anxiety Causes Acne and What You Can Do About it Now!

back to About EUAs

mpox EUA Information

mpox Vaccine EUAs

On November 28, 2022, the World Health Organization announced, and the U.S. government supported, renaming monkeypox disease to mpox. In response to this action by the WHO, federal public health agencies will adopt the mpox name in correspondence with the medical community and American public from this point forward.

Effective August 9, 2022, pursuant to section 564 of the FD&C Act, the HHS Secretary declared:

There is a public health emergency related to monkeypox, or significant potential for a public health emergency, that affects, or has the significant potential to affect, national security or the health and security of United States citizens living abroad that involves monkeypox virus; and
On the basis of this determination, circumstances exist justifying the authorization of emergency use of vaccines.

Vaccine EUAs subsequently issued by FDA are listed in the table below.

PREP Act declaration: Effective September 28, 2022, the HHS Secretary amended the declaration first issued on October 10, 2008, and amended and republished effective January 1, 2016 for smallpox countermeasures and countermeasures against other orthopoxviruses pursuant to section 319F-3 of the Public Health Service Act to emphasize that the declaration applies to monkeypox virus, to expand the categories of providers authorized to administer vaccines and therapeutics against smallpox (variola virus), monkeypox virus, and other orthopoxviruses in a declared emergency, and to extend the duration of the declaration. About PREP Act declarations

mpox In Vitro Diagnostics EUAs

Effective September 7, 2022, pursuant to section 564 of the FD&C Act, the HHS Secretary declared:

On the basis of the August 9th determination, the Secretary of HHS has subsequently declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section. See from HHS: HHS Secretary Becerra Issues 564 Declaration to Expand the Availability of Testing for Monkeypox

Diagnostic EUAs subsequently issued by FDA are listed in the table on this page: Monkeypox Emergency Use Authorizations for Medical Devices.

Xem thêm : What’s the Buzz

Additional information for product developers is available at:

Policy for Monkeypox Tests to Address the Public Health Emergency
Monkeypox Emergency Use Authorizations for Medical Devices (including EUA templates)

Note that FDA previously cleared real-time polymerase chain reaction (PCR) tests that detect non-variola orthopoxvirus DNA, including the virus that causes mpox. Learn more about these tests: Monkeypox Tests (In Vitro Diagnostic (IVD) Devices).

On October 20, 2022, FDA also published lists of certain laboratories that have notified FDA of their laboratory developed monkeypox diagnostic test (LDT), modification to an FDA-cleared or EUA-authorized monkeypox diagnostic test, or laboratory developed monkeypox serology test, as described in Sections IV.A.2, IV.A.3, and IV.C, respectively, of the Policy for Monkeypox Tests to Address the Public Health Emergency. While FDA has not reviewed the laboratory’s validation of the listed tests and has not issued EUAs for these tests, we are providing this information to promote transparency.

For additional information about monkeypox (mpox), see: FDA mpox Response and Monkeypox and Medical Devices.

Xem thêm : How Anxiety Causes Acne and What You Can Do About it Now!

back to About EUAs