Emergency Use Authorizations During the COVID-19 Pandemic: Lessons From Hydroxychloroquine for Vaccine Authorization and Approval

Emergency Use Authorizations During the COVID-19 Pandemic: Lessons From Hydroxychloroquine for Vaccine Authorization and Approval

This Viewpoint uses the FDA's Emergency Use Authorization (EUA) of hydroxychloroquine for COVID-19 treatment to emphasize the costs of premature regulatory authorizations to public health and trust, and proposes the use of advisory committees, requirements for postmarketing surveillance, and ad...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:JAMA : the journal of the American Medical Association 2020-10, Vol.324 (13), p.1282-1283
Hauptverfasser: Thomson, Kyle, Nachlis, Herschel
Format: Artikel
Sprache:eng
Schlagworte:
Advisory committees
Coronaviruses
COVID-19
COVID-19 vaccines
Hydroxychloroquine
Pandemics
Public health
Vaccines
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
Beschreibung
Zusammenfassung:This Viewpoint uses the FDA's Emergency Use Authorization (EUA) of hydroxychloroquine for COVID-19 treatment to emphasize the costs of premature regulatory authorizations to public health and trust, and proposes the use of advisory committees, requirements for postmarketing surveillance, and adherence to standards of transparency for any future EUAs.
ISSN:0098-7484
1538-3598
DOI:10.1001/jama.2020.16253