SPADA Meeting Book

7.0 Creation of data and documentation for regulatory reviews

730

Commented [LN(16]: This whole section needs to be put  in context of the rest of the paper.  It needs a brief intro  paragraph to set the stage.  (Then the following section  could start as is, and wouldn’t need a new starting  sentence.)   Commented [SS17R16]: Will do  Commented [LN(18]: This first section starts a bit  abruptly in a new direction. It might be helpful to have a  starting sentence or paragraph to place this discussion in 

7.1 Emergency Use Authorization (EUA) Authority

731

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (35), the FDA 732 Commissioner may authorize the emergency use of unapproved medical products or unapproved 733 uses of approved medical products for certain emergency circumstances. Before FDA may issue 734 an EUA, the HHS Secretary must first declare that circumstances exist justifying the 735 authorization based on one of four determinations made by either the Secretary of Homeland 736 Security, the Secretary of Defense or the Secretary of HHS of a material threat, an actual 737 emergency or a significant potential emergency involving a Chemical, Biological, Radiological 738 and Nuclear (CBRN) agent or agents, or a disease or condition that may be attributable to such 739 agent(s). More information can be found in the FDA finalized guidance—"Emergency Use 740 Authorization of Medical Products and Related Authorities” (36). 741 To help prepare for potential and current emergencies, FDA works with medical 742 countermeasure (MCM) developers to prepare Pre-EUA packages, when appropriate. A Pre- 743 EUA package contains data and information about the safety, quality, and efficacy of the 744 product, its intended use under a future or current EUA, and information about the emergency or 745 potential emergency situation. The pre-EUA process allows FDA technical subject matter 746 experts to begin reviewing information and assist in the development of conditions of 747 authorization, fact sheets, and other documentation needed for an EUA in advance of an 748 emergency and also helps to facilitate completion of an EUA request during a current emergency 749 declaration. Note that a pre-EUA can only transition to an EUA if there is a current applicable 750 emergency declaration. Additional information on how to submit a pre-EUA for In Vitro 751 Diagnostics to FDA can be found at the corresponding page at FDA’s website (37). 752

the context of the rest of this manuscript.  Commented [SS19R18]: Ricky Soong

40