FDA outlines product development process to combat

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FDA outlines product development process to combat Wuhan coronavirus

As with the Zika and Ebola virus outbreaks in recent years, the FDA says it may grant emergency use authorizations (EUA) to medical countermeasures, such as diagnostics and therapeutics under Section 564 of the Federal Food, Drug, and Cosmetic Act.

However, before the FDA can issue an EUA, either the Department of Defense (DoD), Department of Homeland Security (DHS) or Department of Health and Human Services (HHS) Secretary must issue an emergency or material threat determination. After one of those determinations is made, the HHS Secretary must issue an emergency declaration justifying emergency use of unauthorized products or unapproved uses of authorized products.

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Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.

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