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. The FDA plans to give drugs for COVID-19 or certain other life-threatening conditions priority when resources are limited. At this point, the agency is still listing the standard PDUFA goal date in letters to drugmakers -- eight months for a priority review and 12 months for a standard review -- and doesn't plan on extending currently established goals except for issues like Intercept Pharmaceuticals (NASDAQ: ICPT) experienced, where the biotech expects to have its approval delayed after submitting additional data to support the approval of obeticholic acid as a treatment for liver fibrosis due to nonalcoholic steatohepatitis.