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FDA Coronavirus (COVID-19) Update: July 15th, 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 posted an updated Coronavirus Treatment Acceleration Program (CTAP) webpage. The webpage provides information about CTAP’s purpose, strategy and operations.

Coronavirus

Coronavirus

Specifically, this revised webpage includes a dashboard showing crucial statistics related to the development of potential COVID-19 Coronavirus therapeutics. Also included are key guidance and links for therapeutic developers, researchers, patients and consumers.

Today, the FDA also released a new FDA Voices, titled An Update and Behind the Scenes: FDA’s Coronavirus Treatment Acceleration Program, in which agency leaders discuss efforts to leverage cross-agency scientific resources and expertise on COVID-19 Coronavirus therapeutic development and review.

There are now more than 510 drug development programs in planning stages for potential therapies for COVID-19 Coronavirus, and as of today, the agency has reviewed more than 230 trials of potential therapies for COVID-19 Coronavirus.

The FDA encourages consumers to test their knowledge about the appropriate use of hand sanitizer with this hand sanitizer quiz, posted today. The quiz provides questions and answers to some of the most frequently asked questions related to hand sanitizer. This quiz can help consumers learn how to correctly use hand sanitizer.

As part of the FDA’s effort to protect consumers, the agency issued warning letters to the following two firms for selling unapproved products in the United States with false or misleading claims that their products can mitigate, prevent, treat, diagnose or cure COVID-19 Coronavirus in people:

  • Health Beauty Love, which offers tincture products, including “E-Munity,” and
  • Kegan Wellness, which offers products, including “She Vitamin C Tablets,” “She+ Tablets”, and “Giloe+ Tablets.”

There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.

Today, the FDA added dexamethasone sodium phosphate to the lists of drugs for temporary compounding by outsourcing facilities and pharmacy compounders during the COVID-19 Coronavirus public health emergency. These updates help address shortages and access concerns affecting some drugs urgently needed for hospitalized COVID-19 Coronavirus patients.

 


 

The updated lists are referenced in the following guidances:

Testing updates:

To date, the FDA has currently authorized 179 tests under EUAs; these include 148 molecular tests, 29 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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