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FDA Coronavirus (COVID-19) Update: November 25th, 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 has published Face Masks, Including Surgical Masks, and Respirators for COVID-19 Coronavirus, a comprehensive new page on FDA.gov with answers to frequently asked questions about face masks, surgical masks, and respirators.

Coronavirus

Coronavirus

The topics covered in this new page include:

  • The basics on face masks, surgical masks, and respirators 
  • Using face masks, surgical masks, and respirators
  • Shortages of face masks, surgical masks, and respirators during COVID-19 Coronavirus
  • The Emergency Use Authorizations for face masks, surgical masks, and respirators
  • Manufacturing and importing face masks, surgical masks, and respirators during COVID-19 Coronavirus
  • Purchasing or donating face masks, surgical masks, and respirators during COVID-19 Coronavirus
  • Reporting shortages or problems with face masks, surgical masks, or respirators

Also today, the FDA posted two templates with recommendations on what to include in EUA requests for serology tests. These templates provide the FDA’s current recommendations on what data and information should be submitted to the FDA in support of an EUA request or Pre-EUA submission for a SARS-CoV-2 antibody test or home specimen collection devices using dried blood spot.

The templates are intended to help test developers provide validation data and other information to the FDA, but alternative approaches can be used.

Serology Template for Test Developers 

  • This template replaces the individual templates for Commercial Manufacturers and Laboratories. In addition, this template includes recommendations on presenting clinical agreement data stratified by time from symptom onset and recommendations for tests with semi-quantitative claims.

 


 

Home Specimen Collection Serology Template for Fingerstick Dried Blood Spot

  • This template includes recommendations for submissions for prescription use only home collection devices that are intended for use by an individual to self-collect fingerstick dried blood spot specimen(s) that are then sent to a clinical laboratory for testing with a SARS-CoV-2 antibody test that is authorized for use with the home collection device.

On November 23rd, the FDA approved an abbreviated new drug application for dexmedetomidine hydrochloride in 0.9% sodium chloride injection, indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting and sedation of non-intubated patients prior to and/or during surgical and other procedures.

The most common side effects of dexmedetomidine hydrochloride injection are hypotension (low blood pressure), bradycardia (slow heart rate), and dry mouth. This drug is listed in the FDA Drug Shortage Database.

The FDA recognizes the increased demand for certain products during the COVID-19 Coronavirus public health emergency, and we remain deeply committed to facilitating access to medical products to help address critical needs of the American public.

This Thanksgiving, join the FDA in saying thanksExternal Link Disclaimer to the farmers, grocery store workers, food manufacturers, packagers, shippers, and food delivery workers for helping to keep food on our tables through the pandemic.

Testing updates:

As of today, November 24th, 291 tests are authorized by FDA under EUAs; these include 225 molecular tests, 59 antibody tests, and 7 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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