Emergency Use Authorization definition

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 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 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.

Examples of Emergency Use Authorization in a sentence

• 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.

• 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.

• 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.

• 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.

• On March 11, 2020, the World Health Organization (“WHO”) declared COVID-19 a global pandemic.On December 11, 2020, the U.S. Food and Drug Administration (“FDA”) issued an Emergency Use Authorization (“EUA”) for the Pfizer-BioNTech vaccine.

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

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 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.

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.

Emergency Use Authorization or “EUA” means such Emergency Use Authorization(s) issued by the FDA for the Products and providing for the manufacturing, marketing and sale of the device, and all modifications, alterations, improvements, or changes thereto.

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.