February 3, 2020Regulatory
The FDA is announcing critical actions to advance development of novel coronavirus medical countermeasures. As with any emerging public health threat, the FDA 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 such outbreaks.
As part of FDA's ongoing commitment to prepare and respond to infectious disease outbreaks, the agency is sharing updates on processes in place to help developers understand the pathways, including Emergency Use Authorization (EUA), that may be available to more rapidly advance and make medical countermeasures available for this virus, including diagnostic tests. The FDA is also issuing key information for the public to help support the timely development of medical products to respond to the current outbreak. In order to support efficient medical product development for novel coronavirus medical countermeasures, today the FDA is launching a landing page that provides key information for the public, including product developers, on the FDA's efforts in response to this outbreak.
Being able to quickly and accurately diagnose patients infected with the novel coronavirus is an essential step in helping patients identify the need for care and mitigate the spread of the virus to additional individuals. Currently, there are no commercially available products that are authorized to detect novel coronavirus; however, the FDA is actively working to facilitate the development and availability of diagnostics that can detect this virus. The agency is working with public health partners to advance and share the reference materials necessary to facilitate diagnostic development.
The FDA is also requesting that diagnostic test sponsors interested in potential EUA for tests to detect 2019-nCoV contact CDRH-EUA-Templates@fda.hhs.gov for further information and templates. Sponsors wishing to develop therapeutics for 2019-nCoV are encouraged to submit information and questions via the FDA's Pre-IND Consultation program.