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.
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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.
Agency would be allowed to require blister packaging for approved opioids, and would have to do more to coordinate with US Customs and Border Protection to detect illicit drugs at the border, under legislative proposals unveiled by Senate HELP Committee Chairman Lamar Alexander.