Draft Emergency Use Authorization Guidance Available for Public Health Stakeholder Comment

May 04, 2016 | Raymond Puerini

The Food and Drug Administration (FDA) recently published updated draft guidance entitled ‘‘Emergency Use Authorization of Medical Products and Related Authorities’’ for public health stakeholder and industry comment. This is an update to the July 2007 Emergency Use Authorization (EUA) guidance to reflect Pandemic and All-Hazards Preparedness Re-authorization Act (PAHPRA) amendments to the EUA authority and the addition of new emergency use authorities (e.g., emergency dispensing orders, expiration dating extensions, etc.). This guidance, once officially approved, will have many potential implications on how medical countermeasures (MCMs) are managed and dispensed in advance of and during public health emergencies.

NACCHO is requesting local health department MCM stakeholders to provide comments on the draft guidance prior to it’s official release. Although the public can comment on any guidance at any time, to ensure that FDA considers comments on this draft guidance before it begins work on the final version, either electronic or written comments should be submitted to FDA by June 3, 2016 (see the Federal Register notice for further details on how to provide comments). Should you have any questions regarding commenting on this draft guidance please contact Raymond Puerini (rpuerini@naccho.org).

Additional FDA EUA and Zika Resources:


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