Coronavirus Disease 2019 (COVID-19) | FDA

Coronavirus Disease 2019 (COVID-19) | FDA

Coronavirus (COVID-19) Update: Daily Roundup May 15, 2020

The U.S. Food and Drug Administration today continued to take action in the ongoing response effort to the COVID-19 pandemic: Today, the FDA issued an updated At-A-Glance that provides a quick look at facts, figures and highlights of agency's response efforts. The FDA issued a Consumer Update, Coronavirus Testing Basics, to provide information about the different types of tests available and the steps involved in obtaining results.  The FDA and Federal Trade Commission (FTC) issued warning letters to two companies for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. 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. The first seller warned, Benjamin McEvoy, participates in the Amazon Associates program. As an Amazon associate, the company earns commissions by promoting the sale of products, including dietary supplements, on the company’s website, with misleading claims that the products can mitigate, prevent, treat, diagnose or cure COVID-19 in people.  The second seller warned, White Eagle Native Herbs, offers herbal products for sale in the U.S. with misleading claims that the products are safe and/or effective for the treatment and prevention of COVID-19.

The FDA is changing the hours for the COVID-19 Industry Hotline (1-888-INFO-FDA, press *). The FDA began this 24/7 Hotline on March 12, 2020 to address the many questions that the agency was receiving on topics such as diagnostic testing and personal protective equipment (PPE). Since that time, we have responded to over 12,000 inquiries. To best meet current needs, starting on Monday, May 18, 2020, the Hotline will be operating from 8:00 a.m. to midnight Eastern Time Monday-Friday and 8:00 a.m. to 8:00 p.m. Eastern Time on weekends and holidays. For urgent inquiries, the FDA Emergency Line (1-866-300-4374) remains available after-hours. The FDA has also published and continues to update extensive resources on COVID-19 and medical devices to help answer questions. In addition, the FDA published Contacts for Medical Devices During the COVID-19 Pandemic, a detailed list of email addresses that may be used to ask questions about COVID-19 related to specific devices, Emergency Use Authorizations (EUAs) or guidance documents today. Yesterday, the FDA issued an EUA for the G Medical VSMS ECG Patch intended to be used by health care professionals in the hospital setting for remote monitoring of the QT interval of an electrocardiogram (ECG) in general care patients who are 18 years of age or older and are undergoing treatment for COVID-19 with drugs that can prolong QT intervals (measurements used to evaluate some of the electrical properties of the heart) and may cause life-threatening arrhythmias (such as, hydroxychloroquine or chloroquine, especially when used in combination with azithromycin). The VSMS Patch is not intended for use on critical care patients. Such remote monitoring may reduce health care professional exposure to SARS-CoV-2, the virus that causes COVID-19.

The FDA added more content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” The new content includes information on reporting serious adverse events (SAEs) among patients with COVID-19 in certain clinical trials that are not focused on developing COVID-19 therapeutics.  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 100 tests under EUAs, which include 87 molecular tests, 12 antibody tests, and 1 antigen test.

Coronavirus Disease 2019 (COVID-19)