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 the issuance by the FDA or other applicable Regulatory Authority of an Emergency Use Authorization for any Product Candidate or Product.
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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.
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Examples of Emergency Use Authorization in a sentence

  • Administered in accordance with the FDA approval or the FDA Emergency Use Authorization as applicable.

  • I strongly oppose any such measure and remind you that these vaccines are currently not approved for uptake in children ages 5-17 by the United States Food and Drug Administration (FDA); rather they have been authorized by the FDA under an Emergency Use Authorization (EUA).

  • Under FDA Circular No. 2020-036 or the Guidelines for the Issuance of Emergency Use Authorization for Drugs and Vaccines for COVID-19, the pharmacovigilance obligations and post-authorization commitments imposed in the Letter shall be shared to the fullest extent possible and applicable by the national procurer and health program implementors, and their designees.

  • Test for COVID-19 with either a polymerase chain reaction (PCR) or antigen test has an Emergency Use Authorization (EUA) by the FDA or is operating per the Laboratory Developed Test requirements by the U.S. Centers for Medicare and Medicaid Services.

  • 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.

  • The list of respirators approved under this Emergency Use Authorization (EUA) is in Appendix B to this letter, updated at https://www.fda.gov/media/ 135921/download.

  • Plan should include a tentative schedule for regulatory milestones.b. Establishment and filing of regulatory submissions to the correct office with the FDA.c. Maintenance of a plan for additional studies to support future filing for FDA- approval/clearance.d. Development of a potential Plan for consideration of an Emergency Use Authorization (EUA) of a medical product when appropriate.

  • Individuals will only be considered fully vaccinated after they have received a COVID-19 vaccine that is currently authorized for Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA) or the World Health Organization (WHO), or that are approved for use by the same.

  • Under FDA Circular No. 2020-036 or the Guidelines for the Issuance of Emergency Use Authorization for Drugs and Vaccines for COVID-19, the pharmacovigilance obligations and post-authorization commitments imposed in the Letter shall be shared to the fullest extent possible and applicable by the national procurer and health program implementors.

  • Training resources and materials will also be available on the DOH website.• Providing Emergency Use Authorization (EUA) fact sheets or VISs to vaccine recipients - In person and/or virtual training will be provided by DOI field staff.


More Definitions of Emergency Use Authorization

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.
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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.
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Emergency Use Authorization or “EUA” shall mean 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.
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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.
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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.
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Related to Emergency Use Authorization

  • Service Authorization means that Open Ecosystem Partner needs to meet specific qualification requirements for the products included in a “Service” Product Family that Open Ecosystem Partner wants to promote and offer Services for as set out in detail in the Open Ecosystem Program Guide.

  • Private Authorizations means all franchises, permits, licenses, approvals, consents and other authorizations of all Persons (other than Governmental Authorities).

  • Federal work authorization program means any of the electronic verification of work authorization programs operated by the United States Department of Homeland Security or any equivalent federal work authorization program operated by the United States Department of Homeland Security to verify information of newly hired employees, pursuant to the Immigration Reform and Control Act of 1986 (IRCA), D.L. 99-603.

  • Government Authorizations means all such approvals, consents, authorizations, acknowledgements, licenses or permits required to be issued by any Government Authority to the Company for the establishment of the Company or to the Company or the Contractors for the construction, financing, ownership, operation, and maintenance of the Facility by the Company or the Contractors, including, without limitation, those Government Authorizations listed in Schedule 1;

  • ACH Authorization means the ACH Debit Authorization Agreement in substantially the form of Exhibit H.

  • Water Authority means the body corporate known as the Water Authority of Western Australia established by the Water Authority Xxx 0000;

  • Prior authorization means that we must approve the Services in advance in order for the Services to be covered.

  • Service Authorization Request means a Provider’s or Enrollee’s request to the Contractor for the provision of a service.

  • Product Authorizations means any and all approvals, including applicable supplements, amendments, pre- and post-approvals, clearances, licenses, notifications, registrations, certifications or authorizations of any Governmental Authority, any Standard Body necessary for the manufacture, development, distribution, use storage, import, export, transport, promotion, marketing, sale or other commercialization of a Product in any country or jurisdiction.

  • Work Authorization or "WA" means Buyer’s authorization in either electronic or tangible form for Supplier to conduct transactions under this Agreement in accordance with the applicable SOW (i.e., a purchase order, xxxx of lading, or other Buyer designated document). A SOW is a WA only if designated as such in writing by Buyer.

  • Sell Authorization means that Distributor needs to meet specific training and qualification requirements for each product included in an “On Premise” Product Family that Distributor wants to resell as set out in detail in the Distributor Program Guide and the applicable RSPI.

  • Regulatory Authorizations means all approvals, clearances, notifications, authorizations, orders, exemptions, registrations, certifications, licenses and permits granted by, submitted to or filed with any Regulatory Agencies, including all Product Authorizations.

  • Authorizations means all filings, recordings, and registrations with, and all validations or exemptions, approvals, orders, authorizations, consents, franchises, licenses, certificates, and permits from, any Governmental Authority.

  • Environmental Authorizations means all licenses, permits, orders, approvals, notices, registrations or other legal prerequisites for conducting the business of the Borrower or any Subsidiary required by any Environmental Requirement.

  • Environmental Authorization Any license, permit, order, approval, consent, notice, registration, filing or other form of permission or authorization required under any Environmental Law.

  • Governmental Authorization means any authorization, approval, consent, franchise, license, covenant, order, ruling, permit, certification, exemption, notice, declaration or similar right, undertaking or other action of, to or by, or any filing, qualification or registration with, any Governmental Authority.

  • Government Approvals means all permits, licenses, authorisations, consents, clearances, decrees, waivers, privileges, approvals from and filing with government instrumentalities necessary for the development, construction and operation of the Work.

  • Governmental Consent means any notice to, registration, declaration or filing with, exemption or review by, or authorization, order, consent or approval of, any Governmental Entity, or the expiration or termination of any statutory waiting periods;

  • Governmental Authorizations means, with respect to any Person, all licenses, permits, certificates, waivers, consents, franchises (including similar authorizations or permits), exemptions, variances, expirations and terminations of any waiting period requirements and other authorizations and approvals issued to such Person by or obtained by such Person from any Governmental Authority, or of which such Person has the benefit under any Applicable Law.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Necessary Authorizations means all approvals and licenses from, and all filings and registrations with, any governmental or other regulatory authority, including, without limiting the foregoing, the Licenses and all approvals, licenses, filings and registrations under the Communications Act, necessary in order to enable the Borrower and its Subsidiaries to own, construct, maintain, and operate communications tower facilities and to invest in other Persons who own, construct, maintain, manage and operate communications tower facilities.

  • Compliance Authority means each and all of the (a) U.S. Treasury Department/Office of Foreign Assets Control, (b) U.S. Treasury Department/Financial Crimes Enforcement Network, (c) U.S. State Department/Directorate of Defense Trade Controls, (d) U.S. Commerce Department/Bureau of Industry and Security, (e) the U.S. Internal Revenue Service, (f) the U.S. Justice Department, and (g) the U.S. Securities and Exchange Commission.

  • Consents, Clearances and Permits means all authorizations, licenses, approvals, registrations, permits, waivers, privileges, acknowledgements, agreements, or concessions required to be obtained from or provided by any concerned authority for the purpose of setting up of the generation facilities and/ or supply of power;

  • Fire authority means the department, agency, or public entity with responsibility

  • Authorization Letter means a letter agreement executed by Borrower in the form of EXHIBIT A.