Regulatory Affairs

DOJ Joins Suboxone Whistleblower Cases

The Justice Department filed notice that it plans to intervene in four False Claims Act lawsuits accusing Indivior and Reckitt of improperly marketing the opioid anti-addiction drug Suboxone. Read More

FDA Issues Guidance on Endpoints for Opioid MATs

Drug sponsors may not have to prove that a proposed medicine-assisted therapy helps addicts completely kick opioids but they will have to detail how well it helps cut dependence to win FDA approval, the agency said in a new draft guidance. Read More