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Such discussions might occur prior to the submission of a proper request for consideration of an EUA or issuance by the HHS Secretary of an EUA declaration. Submission of an IND or IDE is not required for potential EUA products, although FDA anticipates that many unapproved products for which an EUA is requested will already be beneath analysis via such mechanisms. In truth, human data derived in the course of studies carried out underneath an IND or IDE might help to help an FDA conclusion that the out there evidence is adequate to assist an EUA consistent with the statutory standards for issuance.

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