FDA Issues Update on Its Actions for Coronavirus Medical Countermeasures

The US Food and Drug Administration (FDA) has outlined its actions to advance development of coronavirus (2019-nCoV) medical countermeasures for the outbreak in Wuhan, China. This includes collaboration 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 outbreaks.

In order to support efficient medical product development for coronavirus medical countermeasures, 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. The FDA says it is closely collaborating with domestic and international public health partners as well as employing public health authorities to facilitate development and availability of investigational medical products.

Currently, there are no commercially available products that are authorized to detect coronavirus; however, the FDA says it is actively working to facilitate the development and availability of diagnostics that can detect the virus. The agency says is working with public health partners to advance and share the reference materials necessary to facilitate diagnostic development.

The FDA 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 the coronavirus, including diagnostic tests.

The FDA is also requesting that diagnostic test sponsors interested in potential EUA for tests to detect 2019-nCoV contact the FDA. Additionally, sponsors wishing to develop therapeutics for 2019-nCoV are encouraged by the FDA to submit information and questions via the FDA’s Pre-IND Consultation program.

This week, Johnson & Johnson announced its places to address the coronavirus, including initiating development of a vaccine candidate. See related story, J&J Initiates Vaccine Development for Coronavirus in Response to Outbreak.

Source: US Food and Drug Administration




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