Could Internet Be Path To Simplifying Participation In REMS?
Suggestions to FDA on improving REMS assessments include providing access to patient and physician surveys through a single website and timing assessments based on product launch, not REMS approval.
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REMS assessment schedule for the long-acting/extended release opioid products reflects the large number of drugs, prescribers and patients involved in the risk management program and the time needed to put all its components in place.
An FDA-convened panel of experts finds no single best question format for ascertaining patients’ and prescribers’ knowledge about drug risks learned through Risk Evaluation and Mitigation Strategies.
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.