Regulatory Affairs

EMA Calls for Details, Narratives in Marketing Applications

Drugmakers need to provide adequate details — and include narratives — in describing manufacturing processes in their applications, but can leave out elements such as machinery serial numbers and general GMPs, according to the European Medicines Agency. Read More

Invidior Plans to Appeal Verdict in Suboxone Patent Case

Facing a drastic loss of revenue and market share to a competing generic drug, Indivior said it will appeal an adverse federal court ruling on its patent for Suboxone (buprenorphine and naloxone), a sublingual film indicated for the maintenance treatment of opioid dependence. Read More