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FDA Coronavirus (COVID-19) Update: July 11th, 2020

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:

The FDA issued a statement in conjunction with preparations to resume domestic inspections, guided by a new a risk-assessment system.

Coronavirus

Coronavirus

The White House Guidelines for Opening Up America Again are providing FDA a roadmap for optimizing operations and new work arrangements, and the U.S. Centers for Disease Control and Prevention’s (CDC) guidance is informing efforts related to workplace exposures to COVID-19 Coronavirus in non-healthcare settings.

To arm FDA investigators with the most reliable and accurate information, the FDA developed a rating system to assist in determining when and where it is safest to conduct prioritized domestic inspections.

The COVID-19 Advisory Rating system (COVID-19 Advisory Level) uses real-time data to qualitatively assess the number of COVID-19 Coronavirus cases in a local area based on state and national data.

The Advisory Level data will be made available to state partners who, under contract, conduct inspections of FDA-regulated entities on the agency’s behalf.

At this time, the agency is working toward restarting on-site inspections during the week of July 20th. However, resuming these inspections will depend on the data about the virus’ trajectory in a given state and locality and the rules and guidelines established by those state and local governments.

The agency issued new Emergency Use Authorizations for diagnostic tests developed by:

Testing updates:

To date, the FDA has currently authorized 173 tests under EUAs; these include 144 molecular tests, 27 antibody tests, and 2 antigen tests.

 


About the U.S. Food and Drug Administration

The U.S. Food and Drug Administration (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.


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