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FDA Develops Strategies to Remedy COVID-19 Pandemic; Alex Azar, Amy Abernethy Quoted

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The U.S. Food and Drug Administration (FDA) has developed a new program across public, academic and private sectors to combat the COVID-19 pandemic, the administration reported on Tuesday

“The FDA is announcing a new, comprehensive public-private approach to bring coronavirus treatments to market as fast as possible," said HHS Secretary Alex Azar. "As part of this new program, the FDA is cutting red tape, redeploying staff and working day and night to review requests from companies, scientists and doctors who are working toward therapies.

The program is designed to expedite the development of potentially safe and effective life-saving treatments. The Coronavirus Treatment Acceleration Program (CTAP) will utilize new tools to develop and deliver therapies to sick patients as quickly as possible, as well as support research to further evaluate whether the treatments are safe and effective for treating patients with COVID-19. 

The facilities that will participate in the program include NanoViricides, Inc., Moderna, Inc., Gilead Sciences, Inc., Inovio Pharmaceuticals, Inc. and Dynavax Technologies Corporation.

In addition to FDA’s program development, the administration also announced that companies across the globe will shift its technologies to help fight the spread of coronavirus, including Biotricity, CytoDyn, Amazon, Clorox and Sorrento Therapeutics. 

At the companies, existing modern solutions in diagnostics and monitoring treatments will be repurposed and being used as tools to help fight the current pandemic. These technologies can help identify outbreak hotspots, prevent infections and reduce the need for physical contact in diagnostics.  

The FDA recently issued an update allowing certain remote diagnostic tools to be used in the fight. The update said: '"Today, as part of the U.S. Food and Drug Administration's ongoing efforts to address the coronavirus outbreak (COVID-19), the agency issued a new policy that allows manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices to expand their use so that health care providers can use them to monitor patients remotely.”

The devices include those that measure body temperature, respiratory rate, heart rate and blood pressure.  

"Allowing these devices to be used remotely can help health care providers access information about a patient's vital signs while the patient is at home, reducing the need for hospital visits and minimizing the risk of exposure to coronavirus," said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. 

Amazon and Conduent Incorporated, a business process services and solutions company, recently announced that its disease surveillance and outbreak management platform, Maven, will be available on Amazon Web Services (AWS). 

Conduent's Maven solution was recently refigured to help public health agencies securely engage patients, and track, manage and report on cases and potential exposures of coronavirus (COVID-19).  

Given the critical need to stop the spread of COVID-19 in the U.S., where Maven is primarily used, Conduent is waiving the software license fee for the Maven COVID-19 module through June 30, 20201 for the qualified state- and territorial-level public health agencies as a means to enable the agencies in the fight against COVID-19.

"This policy reflects the FDA's commitment to ease burdens on health care providers and facilities as they face this public health emergency. Such devices include technologies capable of enabling remote interactions to provide crucial information to be used as an adjunctive when health care providers diagnose or treat COVID-19 or co-existing conditions.," added Abernethy.

About FDA  

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.