Coronavirus (COVID-19) Update: Daily Roundup June 17, 2020

Coronavirus (COVID-19) Update: Daily Roundup June 17, 2020

The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic: On June 16, 2020, the FDA approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated, in addition to general anesthesia, to facilitate tracheal intubation and to induce skeletal muscle relaxation during surgery or mechanical ventilation. Side effects of succinylcholine chloride injection include anaphylaxis, hyperkalemia, and malignant hyperthermia. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain committed to facilitating access to safe and effective medical products to help address critical needs of the American public. Today, the FDA published the Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry. Clinical trials and development across investigational product areas have been impacted by public health measures to control the COVID-19 virus; this guidance shares recommendations on statistical considerations to address the impact of COVID-19 on meeting objectives of clinical trials conducted during this public health emergency. This guidance applies to clinical trials of human medical products and animal drugs. Today, as part of its commitment to protect consumers and patients from fraudulent COVID-19 products and from the potential serious public health risks of these products, the FDA issued warning letters to three manufacturers: Medakit, Ltd., of Sheung Wan, Hong Kong; Antibodiescheck.com and Yama Group; and Dr. Jason Korkus, DDS, and Sonrisa Family Dental d/b/a My COVID19 Club of Chicago, Illinois. The warning letters were issued for marketing COVID-19 tests adulterated and misbranded COVID-19 antibody tests. Violations outlined in the letters include: offering test kits for sale in the United States directly to consumers for at-home use without marketing approval, clearance, or authorization from the FDA; misbranding products with labeling that falsely claims product are “FDA approved”; and labeling that bears the FDA logo, which is only for the official use by the FDA and not for use on private-sector materials. The FDA reminds the public that, at the present time, there are no diagnostic or antibody COVID-19 test kits that are currently authorized, cleared, or approved to be used completely at home. The FDA has authorized several diagnostic COVID-19 tests for use with at-home collection of samples (e.g., nasal, salivary) that can then be sent to a lab for processing and test reporting. However, there are not any antibody tests that are authorized for use with at-home collection of samples.

Testing updates: To date, the FDA has currently authorized 139 tests under EUAs; these include 118 molecular tests, 20 antibody tests, and 1 antigen test.

Additional Resources:

• FAQs on Testing for SARS-CoV-2
• Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)