- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- Today, the FDA updated an immediately in effect guidance, Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. This update expands the scope of the guidance to include an additional device type: Gaseous-Phase Carbon-Dioxide Gas Analyzer (product code CCK), which includes capnographs and devices with a capnography feature.
- Yesterday, the FDA approved two generic drugs indicated to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation: succinylcholine chloride injection USP 200 mg/10 mL and cisatracurium besylate injection USP 10 mg/5 mL. The FDA recognizes the increased demand for certain products during the novel coronavirus pandemic, and we remain deeply committed to facilitating access to medical products to help address critical needs of the American public.
- The FDA issued warning letters to Everything Aquatic and Mr Frags, LLC, which distribute chloroquine phosphate products intended to treat disease in aquarium fish. Chloroquine phosphate has not been approved, conditionally approved, or indexed to treat disease in aquarium fish. Although the chloroquine phosphate products identified in these warning letters did not make claims about use in people, the agency is concerned that consumers may mistake unapproved chloroquine phosphate animal drugs for the human drug chloroquine phosphate. People should not take any form of chloroquine unless it has been prescribed by a licensed health care provider.
- The FDA issued three warning letters jointly with the Federal Trade Commission to Peterson Research Laboratories dba Covercology, Predator Nutrition, and Beepothecary for selling unapproved and misbranded products with fraudulent COVID-19 claims.
- Testing updates:
- As of today, 285 tests are authorized by FDA under EUAs; these include 222 molecular tests, 56 antibody tests, and 7 antigen tests.
The 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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