FDA Deferring Action on Spectrum’s ROLONTIS Application As A Result of COVID-19 Related Travel Restrictions
By EsqSocial Corporation 29/10/20
On Monday, Spectrum Pharmaceuticals announced that the FDA was reportedly unable to conduct its required inspections of Spectrum’s Hanmi Bioplant due to travel restrictions related to the COVID-19 pandemic, and that as a result, the FDA was deferring action on the company’s Biologics License Application for ROLONTIS (eflapegrastim) until the inspections can be completed. President and CEO of Spectrum Joe Turgeon said that the company is “actively working with the FDA to find a way to expedite...
By: Goodwin