FDA to promote development of coronavirus diagnostics and countermeasures
The US FDA has revealed its action plan to aid in the development and advancement of diagnostics and medical countermeasures to combat the novel coronavirus 2019.
The US Food and Drug Administration (FDA) has announced it will collaborate with interagency partners, product developers, international partners and global regulators to expedite the development and availability of medical products needed to diagnose, treat, mitigate and prevent the spread of the novel coronavirus 2019 (nCov-2019).
The FDA Commissioner, Dr Stephen Hahn revealed: “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 help address this urgent public health situation.”
The agency is sharing information with developers on processes, eg, the Emergency Use Authorization (EUA), put in place to rapidly advance availability of countermeasures and diagnostics for the virus. The FDA is also launching a landing page to provide key information to product developers and the public on the efforts in response to the outbreak.
Anna Abram, the FDA Deputy Commissioner of Policy, Legislation and International Affairs said: “The agency is committed to ensuring safe and effective medical countermeasures are available as quickly as possible to protect public health.”
They highlighted that a key step is to ability to quickly and accurately diagnose infected individuals so that the disease is not spread. According to the agency, because there are no authorised products commercially available to detect nCov-2019, the FDA and its partners are working to share reference materials which hopefully will aid the development, advancement and availability of such diagnostics.