Data Bytes: FDA approvals continue at solid pace despite pandemic

FDA’s Center for Drug Evaluation and Research has approved more NMEs in 1H20 than in the first half of any of the previous five years, even as the COVID-19 pandemic disrupts agency site inspections, clinical trials and other operations that keep the U.S. biopharma industry’s regulatory system running smoothly.

Whether FDA reviews remain on track in the second half could be affected by how quickly the agency reopens pre-approval site inspections. The agency halted most in-person site inspections in March due to travel restrictions caused by COVID-19. As site inspections tend to happen early in the review process, the travel restrictions could have a bigger impact on PDUFA dates in the second half of the year than those in the months directly after the halt. ...