Descriptor English: | Emergency Use Authorization |
Descriptor Spanish: | Autorización de Uso de Emergencia |
Descriptor Portuguese: | Autorização de Uso Emergencial |
Descriptor French: | Without translation |
Entry term(s): |
Authorization, Emergency Use Authorizations, Emergency Use EUA Emergency Use Authorizations Use Authorization, Emergency |
Tree number(s): |
N03.706.615.473.125 |
RDF Unique Identifier: | https://id.nlm.nih.gov/mesh/D000098485 |
Scope note: | Authorization allowing the Food and Drug Administration (FDA) to strengthen public health protections against chemical, biological, radiological, and nuclear threats including infectious diseases, by facilitating the availability and use of medical countermeasures needed during public health emergencies. Under section 564 of the Federal Food, Drug, and Cosmetic Act, 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 agents when certain criteria are met, including there are no adequate, approved, and available alternatives.(From fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities) |
Allowable Qualifiers: |
EC economics HI history LJ legislation & jurisprudence |
Public MeSH Note: | 2025 |
History Note: | 2025 |
DeCS ID: | 60845 |
Unique ID: | D000098485 |
Documents indexed in the Virtual Health Library (VHL): | Click here to access the VHL documents |
Date Established: | 2025/01/01 |
Date of Entry: | 2024/08/09 |
Revision Date: | 2024/04/27 |
|
Emergency Use Authorization
- Preferred
Concept UI |
M000766740 |
Scope note | Authorization allowing the Food and Drug Administration (FDA) to strengthen public health protections against chemical, biological, radiological, and nuclear threats including infectious diseases, by facilitating the availability and use of medical countermeasures needed during public health emergencies. Under section 564 of the Federal Food, Drug, and Cosmetic Act, 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 agents when certain criteria are met, including there are no adequate, approved, and available alternatives.(From fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities) |
Preferred term | Emergency Use Authorization |
Entry term(s) |
Authorization, Emergency Use Authorizations, Emergency Use EUA Emergency Use Authorizations Use Authorization, Emergency |
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