The U.S. Food and Drug Administration announced Tuesday, the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- The FDA took important actions to help accelerate the development of prevention and treatment options for COVID-19 by providing new guidance with recommendations for innovators and researchers conducting work in this area. These guidance documents aim to make the process for submitting applications to initiate studies for new drugs and biological products more efficient by outlining recommendations for ways to design clinical trials to evaluate safety and effectiveness of these medical products for COVID-19.
- The FDA provided an update on surveillance inspections during the COVID-19 pandemic. In the update, the agency stated it will continue to utilize and implement additional alternative inspection tools and approaches while postponing domestic and foreign routine surveillance inspections. This will continue as local, national and international conditions warrant, with the exception of certain mission critical inspections.
- The FDA issued a warning letter to one company that was selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. The seller warned, Fusion Health and Vitality LLC, recently offered products, including “CORE” and “IMMUNE SHOT,” for sale in the U.S. with claims that misleadingly represented the products as safe and/or effective for the prevention and treatment of COVID-19. 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.
- To date, the FDA has posted 48 COVID-19 related warning letters.
- The FDA posted updated information for blood establishments regarding COVID-19, which aligns with the agency’s guidance on convalescent plasma to allow donation 14 days after complete resolution of symptoms. The posting also provides updated information blood establishments may wish to consider when evaluating prospective blood donors.
- Yesterday, the FDA issued an Emergency Use Authorization (EUA) for the Ascom teleCARE IP Nurse Call System for use by healthcare providers and patients in healthcare environments, including temporary hospital facilities, to facilitate remote communication between patients and healthcare providers. The remote communication and monitoring capabilities of the teleCARE IP Nurse Call System may reduce the amount of contact by healthcare providers with patients who are in isolation rooms, thereby reducing healthcare provider risk of exposure to SARS-CoV-2, the virus that causes COVID-19.
- Yesterday, FDA issued an EUA for the emergency use of the Eko electrocardiogram (ECG) Low Ejection Fraction Tool (“ELEFT”) to be used by healthcare professionals to provide an assessment of Left Ventricular Ejection Fraction as a diagnostic aid to screen for potential cardiac complications associated with COVID-19 or underlying cardiac conditions that may affect clinical management of COVID-19, in adult patients having or suspected of having COVID-19. The EUA was issued to Manatt, Phelps & Philips.
- Testing updates to date:
- During the COVID-19 pandemic, the FDA has worked with more than 500 test developers who have said they will be submitting EUA requests to the FDA for tests that detect the virus.
- To date, FDA has authorized 93 tests under EUAs, which includes 12 antibody tests and 1 antigen test.
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.