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FDA Coronavirus (COVID-19) Update: December 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:

Yesterday, the FDA posted the review memorandum outlining the basis of the agency’s decision to authorize the Pfizer-BioNTech COVID-19 Vaccine.

Coronavirus

Coronavirus

To ensure all Americans can have trust and confidence in the carefulness of FDA’s review, we have made, and will continue to make, the vaccine review process as transparent as possible.

As part of the FDA’s effort to protect consumers, the agency issued warning letters jointly with the Federal Trade Commission to Indigenous Products, Heavenly Natural Products and Health & Wellness Center International One, L.L.C. dba Hotze Vitamins, three firms that sell unapproved and misbranded products with fraudulent COVID-19 Coronavirus claims, and iThrive.Health, a firm that promotes and participates in the sale of such products. Consumers concerned about COVID-19 Coronavirus should consult with their health care provider.

On December 11th, the agency approved an abbreviated new drug application for midazolam injection, indicated for preoperative sedation/anxiolysis (anxiety)/amnesia; as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures; for induction of general anesthesia; and as a continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.

The most common side effects of midazolam injection are respiratory rate decrease, apnea (temporary stopping of breathing), as well as variations in blood pressure and pulse rate. This drug is included in the FDA’s 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.

To protect consumers of fraudulent products and as part of ORA’s COVID-19 Operation Quack Hack (OCI), the U.S. Attorney’s Office in the Southern District of California recently issued a press release to announce that a San Diego physician was indicted by a federal grand jury earlier this month for selling COVID-19 Coronavirus “treatment kits,” which he advertised to one potential customer as a “miracle cure.” In April, Dr. Staley was charged with one count of mail fraud related to this scheme.

The current indictment includes additional charges for Dr. Staley’s smuggling hydroxychloroquine powder as ‘yam extract’ from a Chinese supplier, and posing as a former employee to obtain hydroxychloroquine pills that he resold as part of his treatment kits.  

 


 

The FDA has posted a video on safely using hand sanitizerExternal Link Disclaimer, with tips for consumers and their families on how to use and store hand sanitizer, as an alternative when handwashing with soap and water isn’t possible.

Testing updates:

As of December 14th, 299 tests and sample collection devices are authorized by FDA under EUAs; these include 230 molecular tests and sample collection devices, 61 antibody tests, and 8 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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