NCIt related terms : Emergency Use Authorization (EUA); EUA;
CISMeF acronym : EUA;
Alternative definition : FDA: The EUA is a statutory authority allowing the Secretary of the Department of
Health and Human Services (HHS) to authorize the introduction into interstate commerce
and the use of unapproved medical products or authorize unapproved uses of approved
medical products intended for use in an actual or potential emergency, during an emergency
declared under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act), as amended by the Project BioShield Act of 2004 (Public Law 108-276).; CDISC-GLOSS: Approval by FDA for the emergency use of certain unapproved medical products
or an unapproved use of an approved medical product for certain emergency circumstances,
when applied for under a declared health emergency. These medical products may be
referred to as medical countermeasures (MCMs) and may include drugs, biologics, and
devices. [After Emergency Use Authorization of Medical Products and Related Authorities.
FDA Guidance for Industry and Other Stakeholders. January 2017.] See also pre-approval
access.; MRCT-Ctr: A process to make a treatment or vaccine available during a public health
emergency, before all research is complete, and before full approval is granted. (https://mrctcenter.org/glossaryterm/emergency-use-authorization-eua/);
Currated CISMeF NLP mapping