Emergency Use Authorization definition

Emergency Use Authorization or “EUA” means an authorization by the FDA under section 564 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3) whereby certain unapproved medical products or unapproved uses of approved medical products may nonetheless be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biologic, chemical, or nuclear agents when there are no adequate approved and available alternatives.

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Emergency Use Authorization means an authorization issued by a Stringent Regulatory Authority to facilitate the availability and use of medical countermeasures, including vaccines, during a declared state of public health emergency.

Emergency Use Authorization means emergency use authorization pursuant to Section 564 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.A. 301 et. seq.

Examples of Emergency Use Authorization in a sentence

• Perform serology testing with an FDA Emergency Use Authorization (EUA) authorized serological assay as appropriate to respond to emerging pandemics in order to conduct surveillance for past infection and monitor community exposure.

• Printed Materials: • COVID-19 Screening Checklist • DSHS-supplied Event Materials (Banners, Welcome Signs, Posters, etc.) • Event Signage • HIPAA Privacy Statement • ImmTrac2 Consent Forms • Emergency Use Authorization (EUA)/Vaccine Information Statement (VIS) • EUA/VIS Addendum.

• Any PCR (molecular) or antigen test used must either have Emergency Use Authorization by the U.S. Food and Drug Administration or be operating per the Laboratory Developed Test requirements by the U.S. Centers for Medicare and Medicaid Services.

• Any of the above tests must either: (i) have Emergency Use Authorization by the U.S. Food and Drug Administration; or (ii) be operating per the Laboratory Developed Test requirements by the U.S. Centers for Medicare and Medicaid Services.

• FDA-authorized vaccinations include vaccinations that have been authorized pursuant to an Emergency Use Authorization.

More Definitions of Emergency Use Authorization

Emergency Use Authorization means the issuance by the FDA or other applicable Regulatory Authority of an Emergency Use Authorization for any Product Candidate or Product.

Emergency Use Authorization means a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during a declared Public Health Emergency. Under an Emergency Use Authorization, the Food and Drug Administration (“FDA”) may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.

Emergency Use Authorization or “EUA” means an emergency use authorization issued by the FDA pursuant to Section 564 of the FDCA. The duration of an EUA depends in part on the duration of the declaration of the U.S. Department of Health and Human Services (“HHS”) that supports the EUA. The HHS declaration must be current for an EUA to remain in effect. The HHS declaration terminates upon the earlier of (a) HHS determining that the circumstances justifying the EUA’s issuance no longer exist or (b) a change in the approval status of the product such that an EUA would no longer be needed. For the purposes of this definition, any references to the FDA, HHS, statutes, or declaration, duration and termination of an EUA, or approval status of a given product, shall, in each case, include any equivalent Regulatory Authority, agency, statute, or declaration, duration and termination of an EUA in any jurisdiction other than the United States.

Emergency Use Authorization means the FDA’s Regulatory Approval of the use of a Product for an emergency indication in the US and any analogous provisions in any other Major Country.

Emergency Use Authorization means an emergency use authorization, or any analogous approval for emergency situations, granted by a Governmental Authority or Regulatory Authority to warrant limited or conditional distribution of a pharmaceutical or vaccine product, including any granted pursuant to §564 of the FD&C Act (or any equivalent or comparable authorization granted by a Regulatory Authority elsewhere), in each case which is separate from a Market Authorization Approval.

Emergency Use Authorization or “EUA” means a conditional Marketing Authorization granted pursuant to Section 564 of the FD&C Act to expedite access to medicines to address public health emergencies.

Emergency Use Authorization means an authorization to introduce a medicinal product into interstate commerce in the United States pursuant to Section 564 of the United States Federal Food, Drug, and Cosmetic Act.