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FDA Coronavirus (COVID-19) Update: June 4th, 2020

 

U.S. Food and Drug Administration (FDA)Silver Spring, MDThe U.S. Food and Drug Administration (FDA) continues to take action in the ongoing response to the COVID-19 Coronavirus pandemic:

The FDA announced a new web-based resource, titled Testing Supply Substitution Strategies.

Coronavirus

Coronavirus

This 22-slide PowerPoint file contains detailed information to help support labs performing authorized COVID-19 Coronavirus tests.

This interactive tool includes validated supply alternatives that labs can use to continue performing testing when there is a supply issue with some components of a test. The information in this resource is not intended to alter any already issued EUA for a COVID-19 Coronavirus diagnostic test nor is it intended to speak to any specific FDA regulatory requirement.

Rather, the information is being provided to help address availability concerns regarding certain critical components of COVID-19 Coronavirus diagnostic tests during this pandemic. To navigate through the strategies in the file, download the file, open it, and click Slide Show > From Beginning.

The FDA added content to the question-and-answer appendix in its guidance titled Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. The updated guidance has a new question-and-answer pertaining to 21 CFR Part 11 compliance for electronic systems used to generate electronic signatures on clinical trial records.

The guidance cites the COVID MyStudies App as an example of an electronic method for obtaining informed consent securely when face-to-face contact is not possible.

In addition, the guidance further expands on an existing question-and-answer about remote clinical outcomes assessments (COAs) to include four types of COAs: performance outcomes, interview-based clinician-reported outcomes, patient-reported outcomes, and observer-reported outcomes.

Today, the FDA issued an alert to health care professionals regarding a temporary absence of the “paralyzing agent” warning statement on the vial caps of two neuromuscular blocking agents: vecuronium bromide for injection and rocuronium bromide injection. The temporary distribution helps increase the supply of these high-demand drugs used in patients requiring medical ventilation.

Testing updates:

During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted, or said they will be submitting, EUA requests to the FDA for tests that detect the virus or antibodies to the virus.

To date, the FDA has authorized 120 tests under EUAs, which include 104 molecular tests, 15 antibody tests, and 1 antigen test.

 


 

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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