FDA Wants Fast Turnaround In Assessing Opioid REMS' Effectiveness
The agency tells companies to submit proposals in 120 days, and expects to have the REMS in place by the beginning of 2012. The first assessment would be due at six months.
The agency tells companies to submit proposals in 120 days, and expects to have the REMS in place by the beginning of 2012. The first assessment would be due at six months.