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Spring 2020 - Safety

FDA Initiates Coronavirus Medical Countermeasures

The U.S. Food and Drug Administration (FDA) is taking critical actions to advance development of novel coronavirus medical countermeasures. As with any emerging public health threat, 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 outbreaks. The agency is also 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. In addition, FDA is issuing key information for the public to help support the timely development of medical products to respond to the current outbreak.

To support efficient medical product development for novel coronavirus medical countermeasures, FDA launched a landing page that provides key information for the public, including product developers, on the agency’s efforts in response to this outbreak. FDA is also requesting diagnostic test sponsors interested in potential EUA for tests to detect the current coronavirus to contact [email protected] for further information and templates. Sponsors wishing to develop therapeutics for the coronavirus are encouraged to submit information and questions via the FDA’s Pre-IND Consultation program.

“We have a vital mission to protect and promote public health, and the FDA is closely collaborating with our domestic and international public health partners to mitigate the impact of the novel coronavirus that emerged in Wuhan, China,” said FDA Commissioner Stephen M. Hahn, MD. “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.”

References

FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures. U.S. Food and Drug Administration press release, Jan. 27, 2020. Accessed at www.fda.gov/news-events/press-announcements/fda-announces-key-actions-advancedevelopment-novel-coronavirus-medical-countermeasures.

BSTQ Staff
BioSupply Trends Quarterly [BSTQ] is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace. With timely and critical information, each themed issue covers topics ranging from product breakthroughs, industry insights and innovations, up-to-the-minute news on the latest clinical trials, accessibility, and service and safety concerns.