FDA Says COVID-19 Could Delay Drug Approvals
The Food and Drug Administration is getting stretched thin, with staff resources shifting toward COVID-19-related work. So much so, that the agency thinks it's possible it may not meet the goals set forth in the Prescription Drug User Fee Act (PDUFA), which establishes a time frame goal for the agency to make a decision on marketing applications for drugs.
"With many staff members working on COVID-19 activities, it is possible that we will not be able to sustain our current performance level in meeting goal dates indefinitely. We anticipate that the New Drugs Program and the Biologics Program may need to allocate resources to focus on certain activities," the FDA wrote in a guidance document.
The FDA plans to give drugs for COVID-19 or certain other life-threatening conditions priority when resources are limited. While that certainly makes sense, it could delay the approvals of some me-too drugs.
Source Fool.com
