FDA awards first ever Drug Shortage Assistance Award to Regulis client

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.