COVID-19 FDA Response: Guidance Released For Conduct Of Ongoing Trials

By Monica Frazier

Since the emergence of Coronavirus Disease 2019 (COVID-19) in the US, the FDA has released new guidance and information rapidly and continuously in a comprehensive response to the current pandemic. The Agency is tasked with managing a complex situation, including processing a flood of new requests related to potential products for the treatment of COVID-19, monitoring for drug shortages and manufacturing needs associated with products approved for other indications that have been noted to have potential to treat COVID-19, as well as investigating COVID-19 treatment claims. Importantly, the FDA is also focused on the multitude of clinical trials for other indications ongoing prior to and throughout the pandemic. These clinical trials include products that may result in life saving therapies across a spectrum of indications, and must be carried on in a way that will retain the trial data integrity without adversely impacting subject safety. This is an expectation at any time, but FDA recognizes that the current situation presents some new and unexpected challenges.