EMERGENCY USE AUTHORIZATION: AT ZERO HOUR

  • V. Balamuralidhara
  • Vaishnav A.M.
  • Bachu V.
  • Pramod Kumar T.M.

Abstract

The Emergency Use Authorisation (EUA) authority plays a vital role in US FDA. They provide the authority/permission to use the unregistered products/registered product with unregistered route to treat the life threatening damages to the patients in world in some emergency conditions. The aim of this work is to give an overview on EUA in life threatening conditions and there challenges in getting the permissions under regulations with example of E-bola virus. The e-bola is a virus. It is a hemorrhagic fever deadly disease caused by one of the E-bola viral strain, which is wide spread in West Africa. The -Secretary of the Department of homeland security (DHS), determined, pursuant to section 319F-2 of the Public Health Service Act, that the Ebola virus presents a material threat against the United States population sufficient to affect national security. Issuance of EUA by the FDA Commissioner requires several steps under section 564 of the FD&C Act. The FDA Commissioner, can only issue the EUA, if criteria for issuance under the statute are met. This study’s highlights the importance of the EUA in emergency when there is no medicine for disease/virus in the world. For example the FDA has issued a EUA to use the ReEBOV which is the Rapid Antigen Test device designed by Lusys lab co. Pvt. Ltd. for detecting the Zaire Ebola virus.

Keywords: Emergency authorisation, Zaire Ebola virus, ReEBOV, Unregistered product.

Downloads

Download data is not yet available.

References

1. Emergency Use Authorization for Oral Formulations of Doxycycline for Post ¬ Exposure Prophylaxis of Inhalational Anthrax [Internet]. FDA; 2005 [cited 2015 Oct 11]. Available from:
http://www.fda.gov/EmergencyPreparedness/Counterterrorism/ucm269226.htm
2. Summary of Process for EUA Issuance, Issuance EUA. [Internet]. FDA; 2015 [cited 2015 Oct 13]. Available from:
http://www.fda.gov/emergencypreparedness/counterterrorism/medicalcountermeasures/mcmlegalregulatoryandpolicyframework/ucm411445.htm
3. Lewis S. Bavarian nordic announces that the oxford vaccines group has initiated a phase 2 study of the ebola prime-boost vaccine regimen combining mva- bn ® filo and janssen’ s advac ® technology [Internet]. Bavarian Nordic; 2015 [cited 2015 Oct 03]. Available from:
http://www.bavarian-nordic.com/investor/news/news .aspx?news=4491
4. Centers for Disease Control and Prevention (CDC), About Ebola virus disease [Internet]. CDC; 2014 [cited 2015 Oct 12]. Available from:
http://www.cdc.gov/vhf/ebola/about.html
5. e bola virus pics ¬ Google Search [Internet]. Google; 2015 [cited 2015 Nov 26]. Available from:
https://www.google.co.in/search?q=e+bola+virus+pics&espv=2&biw=1242&bih=566&source=lnms&tbm=isch&sa=X&ved=0CAYQ_AUoAWoVChMIj_DYt77syAIVBuKmCh0qLwho
6. Emergency Use Authorization MCM Legal, Regulatory and Policy Framework, Emergency Use Authorization [Internet]. FDA; 2015 [cited 2015 Oct 16]. Available from:
http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryandPolicyFramework/ucm182568.htm#cepheid
7. Emergency Use Authorization (EUA) ¬ All Items All Items [Internet]. U.S Department of Health and Human Services; 2015 [cited 2015 Oct 03]. Available from:
http://www.phe.gov/emergency/news/healthactions/Lists/EUA/AllItems.aspx
Statistics
242 Views | 254 Downloads
How to Cite
Balamuralidhara, V., V. A.M., B. V., and P. K. T.M. “EMERGENCY USE AUTHORIZATION: AT ZERO HOUR”. International Journal of Drug Regulatory Affairs, Vol. 3, no. 4, Feb. 2018, pp. 18-23, doi:10.22270/ijdra.v3i4.173.

Most read articles by the same author(s)