The US Food and Drug Administration (FDA) has maintained its position as a resource for life-sciences companies and consumers alike who are on the hunt for COVID-19 updates and information. Read on for the latest pandemic-related news.
Research contract
The agency awarded a new research contract to the University of Liverpool and its global partners to sequence and analyze samples from humans and animals. The purpose of the project is to create profiles of various coronaviruses, including SARS-CoV-2, which causes COVID-19.
According to researchers ,the study also will examine in vitro coronavirus models, such as organs-on-chips. This regulatory science project, awarded in collaboration with the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIH/NIAID), is intended to help inform development and evaluation of medical countermeasures for COVID-19.
COVID-19 response update
The FDA issued another updated version of its FDA COVID-19 Response At-A-Glance Summary document. The resource offers a roundup of facts, figures, and highlights of the agency's ongoing response efforts.
Information contained in the latest version includes:
- Emergency use authorizations (EUAs) granted for COVID-19 tests and treatments
- Impact of the pandemic on drug shortages
- Updated information on resources like the CURE ID app, which allows healthcare personnel to share experiences in treating COVID-19 patients
- Guidance documents on various topics related to policies, regulations and public health issues
Test update
The FDA published comparative performance data for a number of authorized COVID-19 molecular diagnostic tests. The tables show the Limit of Detection (LoD) of more than 55 authorized molecular diagnostic COVID-19 tests against a standardized sample panel provided by the FDA.
The FDA provided these standardized samples, known as a reference panel, to test developers who are required to assess their test’s performance against this panel (or other FDA-recommended reference materials) as a condition of their Emergency Use Authorization (EUA). To date, the agency has authorized a total of 249 tests under EUAs, including 198 molecular tests, 47 antibody tests, and 4 antigen tests.
Fraudulent COVID-19 products
To date, the FDA has approved no consumer products designed to prevent, treat or cure COVID-19. However, that has not stopped a number of companies from releasing products that falsely claim to do so, including a number of companies receiving warnings for their actions
- Two sites, www.extrapharma.com and www.medication-house.com, were slapped on the wrist for marketing unapproved COVID-19 products.
- The FDA and Federal Trade Commission (FTC) jointly issued a warning to Pharmacy Plus Inc. (dba Vital Care Compounder) for selling its “COVID PACK” and “COVID ‘POSITIVE’ PACK” products.
- The FDA and FTC also chastised 1 Party At A Time for selling a niacin based named BetterFly.
- Lattice Biologics Ltd. received an official warning for marketing an unapproved amniotic fluid product, referred to as AmnioBoost.
