REMS Assessment Challenges Shine Through In Opioids Review
Longitudinal studies and possibly a randomized, controlled trial are needed, FDA's advisory committee says; panelists were underwhelmed by product sponsors' survey, surveillance and drug utilization data.
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Is The Opioid REMS Too Big To Study?
US FDA’s workshop to discuss new ideas to assess the impact of the opioid REMS comes after the industry collaboration behind the REMS has deemed the task essentially impossible.
FDA Expanding Opioid REMS To Immediate Release Formulations
Commissioner Gottlieb tells opioid scientific workshop that updated REMS will also require training to be available to nurses and pharmacists; agency beginning new study on prescriber perceptions.
Postmarketing Studies On Abuse-Deterrent Opioids Could Get New Look
Data sources and methodologies to evaluate real-world effects of abuse-deterrent formulations will be focus of US FDA public meeting in July; value and feasibility of assessing the public health effects of such products more broadly is up for discussion.