CDC Emergency Use Authorization Course

Description:

Course Overview

Course Quality Rating

TBD

Course Description

This toolkit is provided by CDC - Centers for Disease Control and Prevention and will require a secondary login and/or registration. 

An Emergency Use Authorization, or EUA, allows the use of drugs, biologics and medical devices that are not approved, licensed or cleared respectively (i.e., "unapproved medical products") in an emergency to diagnose, treat, or prevent a serious or life-threatening disease or condition when there are no adequate, approved, or available alternatives. 

The medical product that is subject to the EUA may be a product that

• has never been approved, or

• has been approved for some other use, but not for the use required by the emergency. 

During biological, chemical, radiologic, or nuclear incidents, the use of medical products under an EUA may be an element of the public health response.                                                                                  

Click the LAUNCH button below to start or be taken to the course.

Target Audience

This course is designed for state or local public health officials, emergency managers, or a state or local SNS coordinators. 

Learning Objectives

Having completed this course, the learner will be able to:

  1. Define Emergency Use Authorization (EUA) as set forth by the Project BioShield Act of 2004.
  2. Summarize the steps that the U.S. Secretary of Health and Human Services and the FDA Commissioner must take for an EUA to be issued.
  3. Identify the conditions for the use of an unapproved medical product under an EUA.
  4. Identify the differences between an EUA, and Investigational New Drug (IND) application and an Investigational Device Exemption (IDE).

Council of Linkages Core Competencies for Public Health Professionals (COL)/COL Tier(s)

  1. Competencies XX.B (Tier 2):
  2. 2A.9 (Tier 1): Demonstrate use of informatics
  3. 2B.10 (Tier 2): Incorporate informatics practices
  4. 2C.11 (Tier 3): Oversees public health informatics practices and procedures

Professional/Disciplinary Competencies

FEMA/CDC Bioterrorism Competency Model

  1. 463.02d-Conduct bioterrorism preparedness
  2. 463.17t-Maintain agent protocols

Format

Online/ Archived Webinar

Credit /CEU

None available

Duration

None listed

Specifications

Required: PDF Reader 

Course Publication Date

07/26/2013

Launch