AVA is not currently licensed for PEP; under what mechanism would it be administered?

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Multiple Choice

AVA is not currently licensed for PEP; under what mechanism would it be administered?

When a product isn’t licensed for a specific use like PEP, regulatory pathways exist to provide access for investigational or emergency needs. The two main routes are the Investigational New Drug mechanism, which covers use in research or expanded access under an approved protocol with FDA oversight, and an Emergency Use Authorization, which allows use during a declared public health emergency based on a favorable risk–benefit assessment. For AVA and PEP, clinicians would turn to either an IND or an EUA to administer the product. An EUA can apply in emergencies even if full licensure isn’t in place, while an IND encompasses investigational use, including access through an approved protocol. The option that mentions both mechanisms best captures how AVA could be used in this scenario.

When a product isn’t licensed for a specific use like PEP, regulatory pathways exist to provide access for investigational or emergency needs. The two main routes are the Investigational New Drug mechanism, which covers use in research or expanded access under an approved protocol with FDA oversight, and an Emergency Use Authorization, which allows use during a declared public health emergency based on a favorable risk–benefit assessment. For AVA and PEP, clinicians would turn to either an IND or an EUA to administer the product. An EUA can apply in emergencies even if full licensure isn’t in place, while an IND encompasses investigational use, including access through an approved protocol. The option that mentions both mechanisms best captures how AVA could be used in this scenario.

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