PRVB - FDA Issues Guidance for Clinical Trials During COVID-19 Pandemic
Drug companies have run into another serious problem stemming from the COVID-19 outbreak -- the pandemic is making it harder to run clinical trials for all types of treatments. The Food and Drug Administration requires multiple successful clinical trials before a new drug can be sold to the public. These studies typically require medical professionals and researchers to have in-person contact with patients -- and usually, quite a lot of them. That's getting harder and harder to arrange as people are being advised to stay in their homes as much as possible.
For instance, Provention Bio (NASDAQ: PRVB) just called a halt to a clinical trial because of COVID-19 issues. If more companies do this, it could send vital drug development to the sidelines and delay the arrival of new medications.
In recognition of this, the FDA has issued new guidance for running a clinical trial during this national emergency.