Opioid Packaging Changes Might Deter Abuse – And Generic Competition
Executive Summary
US FDA soliciting ideas for opioid packaging and storage technology development; workshop scheduled for December.
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Sponsors would be required to furnish patients with pre-paid envelopes to mail back unused opioid medications for disposal. Comments on FDA's proposal could follow industry concerns about burden on health care system voiced when the idea was floated in 2018.
FDA Broadens Nicotine Therapy Indication Review With Steering Committee Docket
FDA seeks broader guidance than comments and information submitted at a January public hearing on standards testing and evaluations that could expand the variety of products approved as NRTs The docket is open to "recommend specific topics for direct, collective engagement and consideration by the" steering committee.
FDA Broadens Nicotine Therapy Indication Review With Steering Committee Docket
FDA seeks broader guidance than comments and information submitted at a January public hearing on standards testing and evaluations that could expand the variety of products approved as NRTs The docket is open to "recommend specific topics for direct, collective engagement and consideration by the" steering committee.