Coronavirus Disease 2019 (COVID-19) | FDA

Coronavirus Disease 2019 (COVID-19) | FDA

Coronavirus (COVID-19) Update: Daily Roundup June 4, 2020

The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic: Today, the FDA issued a new video resource explaining the different categories of tests in the fight against COVID-19: diagnostic tests and antibody tests. As the video explains, diagnostic tests can tell if the tested person currently is infected. Antibody or serology tests detect if the person’s blood contains antibodies to coronavirus. The body produces antibodies when one becomes infected by the virus, and they help the immune system fight off the infection. If an antibody test finds antibodies in the blood, it likely means the person has been previously infected with the virus. Antibody tests do not detect whether a person is currently infected and should not be used to diagnose a current COVID-19 infection. The results from antibody tests can help us better understand questions about exposure to COVID-19. On June 3, 2020, the FDA approved an abbreviated new drug application for dexmedetomidine hydrochloride in 0.9% sodium chloride injection (ANDA 209307), 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, bradycardia 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 public health emergency, and we remain deeply committed to facilitating access to medical products to help address critical needs of the American public. As part of FDA’s effort to protect consumers, the agency issued warning letters to operators of four websites (www.roidsmall.net, www.emedkit.com, www.4nrx.md and www.chloroquineonline.com) that market unapproved and misbranded COVID-19 products. There are currently no FDA-approved drugs to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider. Consumers can visit BeSafeRx to learn about how to safely buy medicine online.

Today, the FDA announced that on Tuesday, June 9, 12:00 pm – 1:00 pm ET, the FDA will launch a webinar series on the topic of Respirators for Health Care Personnel Use during COVID-19 Pandemic. The webinar will provide FDA information and answer questions about emergency use authorizations (EUAs) for respirators, importing respirators, and overall FDA actions to help ensure that health care personnel on the front lines have the necessary supplies of respirators to meet the demand. Hear from speakers, including Stephen M. Hahn, MD, Commissioner of Food and Drugs at the FDA; Jeffrey E. Shuren, MD, JD, Director of the Center for Devices and Radiological Health (CDRH) at the FDA; William H. Maisel, MD, MPH, Director, Office of Product Evaluation and Quality (OPEQ) at CDRH; and Suzanne Schwartz, MD, MBA, Director, Office of Strategic Partnerships and Technology Innovation (OST) at CDRH. We encourage all interested stakeholders to join. Registration is not necessary. Today, the FDA issued a letter to clinical laboratory staff and health care providers about a safety risk with using transport media and SARS-CoV-2 testing platforms that are not compatible. There is a risk of exposure to harmful cyanide gas when certain transport media are used with an incompatible testing platform or laboratory process that uses bleach. Today, the FDA publicly posted test performance data from four more antibody, or serology, test kits on open.fda.gov from its independent performance validation study effort with the National Institutes of Health’s (NIH) National Cancer Institute (NCI). These results are among the first to come from a collaborative effort by the FDA, NIH, Centers for Disease Control and Prevention (CDC) and Biomedical Advanced Research and Development Authority (BARDA). Additional performance data will be made available as the FDA reviews and determines if any further actions are appropriate for those test kits prior to publication.

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.