While COVID-19 vaccines have begun distribution in other corners of the world, the US Food and Drug Administration (FDA) continues to keep an eye on potential preventives and treatments, while offering guidance to professionals working on possible tests and therapies for the virus.
Clinical trial guidance
The agency has beefed up the question-and-answer appendix in one of its research documents, a guidance entitled Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency. The document is intended to serve as an informational resource for sites and sponsors conducting trials for therapies across the spectrum.
The updates include a new Q&A section discussing considerations for disposing unused investigational drug product when a patient participant is unable to return the drug to the study site. Additionally, the document covers potential alternative procedures for getting rid of the excess product, taking care that such procedures do not expose humans to risks from the drug.
The FDA has kicked off its COVID-19 Precision Immunology App-a-thon. Administered via the agency’s PrecisionFDA platform, the app-a-thon was launched to encourage scientists and analytics specialists to work on innovative applications that address the ties between immunity and COVID-19 disease variables.
The first phase of the program (running until January 29) focuses on extracting knowledge from molecular sequencing data from TCRs/BCRs and associated clinical variables. In Phase II, participants will be asked to create research tools and apps to report the outputs from Phase I, so they can be incorporated into an easily interpretable format for healthcare professionals.
Combo COVID-19/flu test
The FDA has given its first authorization to a diagnostic test designed for at-home collection of patient samples for detecting both COVID-19, and influenza A and B. The Quest Diagnostics RC COVID-19 +Flu RT-PCR Test is intended for prescription use along with the Self-Collection Kit for COVID-19 +Flu.
The combination test product is intended for individuals who are suspected of respiratory viral infection consistent with COVID-19 only when the patient’s doctor has approved its use. Approved patients collect the sample in the privacy of their home, then ship it to a Quest Diagnostics laboratory for analysis.
Unauthorized consumer product
The FDA continues to issue warning letters to companies offering consumer products purporting to prevent, treat or cure COVID-19. To date, the agency has approved no such product for direct sale to consumers.
The latest offender, who received a letter issued jointly by the FDA and Federal Trade Commission (FTC) is Rat’s Army. The company had been selling a product named Virus Bioshield, claiming it successfully protects against the effects of the virus.