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However, before FDA can issue an EUA, a specific type of determination must be in place, the HHS Secretary must issue a declaration to justify the issuance of the EUA, the section 564 statutory criteria for issuing an EUA must be met, and FDA must determine that it is safe to use the product beyond its labeled expiration date

At the conclusion of the study, eradication was achieved in 55% of the M+P group, 33% of the P group, and 25% of the M group

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Merrifield, R.B