Indivior Applies for Approval in Treating Opioid Abuse in U.S.

British pharmaceutical leader Indivior Plc announced this week its new drug application (NDA) to the U.S. Food and Drug Administration for its drug treating opioid use disorder (OUD). The drug, RBD-6000 acts as a monthly injectable opioid which in conjunction with...
How the eCTD has Changed Submission Teams

How the eCTD has Changed Submission Teams

New Age Regulatory Operations: How the eCTD has Changed Submission Teams How the eCTD has Changed Submission Teams   In May of this year, regulatory operations leaders will finally begin preparing therapy submissions under one standardized format. The eCTD’s...