The clinical research industry has seen many rapid changes over the past few months due to the continued presence of COVID-19.
With the evolution of this public health emergency, we have seen the FDA take action to provide real-time information and release new guidances, as well as provide Emergency Use Authorization for therapeutics used to detect and/or diagnose the virus.
On February 4, 2020, the HHS Secretary declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19. Shortly after, on February 29, 2020, the FDA issued an immediately in effect guidance with policy specific to development of in vitro diagnostic tests during this public health emergency, which continues to be updated as new information emerges.
What Is The Emergency Use Authorization?
"The Emergency Use Authorization (EUA) authorizes the emergency use of an unapproved drug, an unapproved or uncleared device, or an unlicensed biological product; or (2) an unapproved use of an approved drug, approved or cleared device, or licensed biological product," the guidance states.
The updated authorization provides liability coverage for those entities working to provide both drug and device responses for COVID-19 and will decrease the time between development and patient receipt, which is critical during this public health emergency. The FDA has specifically been using the benefit of EUAs to promptly increase the availability of COVID-19 testing in the United States, as this is one of the most critical steps in fighting the virus.
How Could The EUA Impact Future Clinical Trials?
Therapeutics are also benefiting from the approval of EUAs and has allowed the FDA to swiftly take the lead in clinical trials surrounding the investigation of the use of therapies derived from human blood. The combination of these two efforts, made possible by the use of EUAs, will allow the FDA to more readily provide access to widespread testing and therapies across the nation.
Along with additional guidances, the FDA has also released authorizations and fact sheets to assist those working with EUAs during this uncertain time.
Additional references for Emergency Use Authorization can be found below:
- FDA Resources for COVID-19 EUAs
- About Emergency Use Authorizations
- FDA Regulation of Diagnostic Testing during the Pandemic
- Emergency Use of Unapproved Devices
Do you think the allowance of Emergency Use Authorization will have a positive impact on treating COVID-19 long-term? What are some unforeseen risks that could be associated with the use of EUAs during a public health emergency?
Please let us know your thoughts and any additional questions you may have in the comments below.