ARTICLE | Regulation
Opioid outline
FDA hopes opioid developers can collaborate on newly required postmarket trials
September 23, 2013 7:00 AM UTC
New requirements from FDA mean companies will have to do at least five postmarket studies for long-acting and extended-release opioids. But first, sponsors and the agency must iron out the details, including the endpoints, size and duration of the studies.
In the meantime, the agency has proposed label changes intended to curtail use of the products until the safety data are available...