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FDA releases Coronavirus Update

 

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

The FDA announced that it is leading an effort, working collaboratively with government, industry and academic partners, to develop and implement a protocol that will provide convalescent plasma to patients in need across the country who may not have access to institutions with clinical trials in place. 

Coronavirus

Coronavirus

Convalescent plasma has the potential to lessen the severity or shorten the length of illness caused by Coronavirus (COVID-19).

This collaboration, involving BARDA, the American Red Cross and the Mayo Clinic, will allow for a simplified process for health care providers that will help ensure patient safety while allowing for the collection of needed information about product efficacy.

The FDA anticipates that the effort will be able to move thousands of units of plasma to patients who need them in the coming weeks.

The FDA posted an FAQ answering whether respirators approved under standards used in other countries, such as KN95s, can be used in the U.S. during the Coronavirus (COVID-19) pandemic. The short answer is yes.

In response to continued respirator shortages, the FDA also issued a new Emergency Use Authorization (EUA) for non-NIOSH-approved respirators made in China, which makes KN95 respirators eligible for authorization if certain criteria are met, including evidence demonstrating that the respirator is authentic. Lastly, the FDA revised an immediately in effect guidance to help expand the availability of general use face masks for the general public and respirators (including N95 and KN95) for health care professionals during this pandemic.

To help minimize the potential impact of the Coronavirus (COVID-19) pandemic on new animal drug development, the FDA issued guidance with recommendations for sponsors conducting ongoing studies to support new animal drug development. 

These recommendations are designed to help ensure the safety of animals, their owners, and study personnel, maintain compliance with good laboratory practice regulations and good clinical practices, and maintain the scientific integrity of the data during the Coronavirus (COVID-19) pandemic.

It also addresses questions regarding CVM’s coordination with foreign regulatory authorities during the pandemic. The guidance aligns with similar recommendations for sponsors of human drugs, biologics and medical devices released in March.

The FDA announced it will begin requesting that importers send records required under the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP) rule electronically (or through other prompt means) to the agency as it shifts to conducting these inspections remotely during the Coronavirus (COVID-19) public health emergency.

The FDA is further extending the comment period for the Laboratory Accreditation for Analyses of Foods proposed rule by an additional 90 days. The comment period had previously been extended until April 6th, 2020. However due to the ongoing coronavirus public health emergency, the comment period will now close July 6th, 2020.

The FDA released a guidance document, Temporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID-19 Public Health Emergency, to provide temporary flexibility regarding the packaging and labeling of shell eggs sold to consumers in retail food establishments.

Diagnostics update to date:

  • During the Coronavirus (COVID-19) pandemic, the FDA has worked with more than 240 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
  • To date, 28 emergency use authorizations have been issued for diagnostic tests.
  • The FDA has been notified that more than 125 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
  • The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

Additional Resources:

Consumer Inquiries: 888.INFO.FDA

 


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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