Regulis was pleased to have assisted Clinigen Group to address the shortage of Foscavir® (foscarnet sodium) injection in the US last year.
These efforts related to the US shortage included making Foscavir® available on a named patient basis whilst acquiring the new drug application and submitting post-approval supplements to restart manufacturing with acceptable compliance records. Regulis consultant Julie Turner played a pivotal role, handled the regulatory actions necessary for these activities.
These actions helped to resolve a critical drug shortage affecting patients. The FDA recognised this work by awarding Clinigen with its first ever Drug Shortage Assistance Award. Regulis was delighted to have played a pivotal role in this project.