The US Food and Drug Administration (FDA) has announced critical actions to expedite the development and availability of medical products needed for the diagnosis, treatment and prevention of the coronavirus and related future outbreaks.
They will step up collaboration with inter-agency partners, product developers and global regulators, as part of their ongoing commitment to tackle infectious disease outbreaks. There are currently no approved vaccines or drugs for the current outbreak, though several international drug developers are working on them, including a potential RNA vaccine.
As with other deadly outbreaks such as Zika and Ebola, the FDA says it may issue emergency use authorisations (EUA) for medicines, diagnostics and therapeutics, under Section 564 of the Federal Food, Drug and Cosmetic Act, justifying the emergency use of unauthorised products or unapproved uses of authorised products.
The FDA requests that sponsors interested in EUA for diagnostic tests should contact the Centre for Devices and Radiological Health (CDRH) for more information. Those wishing to develop therapeutics for the Wuhan coronavirus are encouraged to submit information and questions via the Pre-Investigational New Drug (IND) Consultation Program.
“We are actively leveraging the vast breadth of the FDA’s expertise and have begun employing the full range of our public health authorities to facilitate the development and availability of investigational medical products to address this urgent public health situation.”
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