Drug Safety: FDA Pushes To Publicly Release REMS Assessments, Says It Will Improve Plan Design
Proposal would allow stakeholders to see data on REMS goals like provider training and the US FDA’s conclusions about their effectiveness.
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A massive settlement of opioid litigation is intended to end the era of opioid marketing defined by OxyContin. It also like closes the books on efforts to rely on the US FDA to control the prescription abuse crisis.
Additional power would allow the agency to punish 'simple' REMS violations and improve administration of risk management programs, according to a new report looking at FDA's oversight of opioids.
Drug safety focused meetings would once have been almost certain to focus on mandatory risk management plans as a solution. But FDA not only didn’t propose that approach, it actively discouraged its advisors from considering it.