REMS Refinement: Does iPLEDGE’s Evolution Have Lessons For Opioids?
This article was originally published in The Pink Sheet Daily
The Drug Safety and Risk Management and Dermatologic and Ophthalmic Drugs Advisory Committees will assess the risk management program Dec. 1 for lessons about implementing REMS containing elements to assure safe use and selecting assessment metrics.
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The agency offers ‘regulatory flexibility’ for certain requirements of the iPLEDGE REMS for the acne drug if manufacturers address delays in implementing the modified program.
Common registration site for participants in REMS was endorsed by several panel members during a joint meeting of the Drug Safety and Risk Management and Dermatologic and Ophthalmic Drugs Advisory Committees.
Holding less than 5 percent of isotretinoin market and burdened with the costs of personal injury suits, Roche decides to discontinue its acne drug.