FDA Standardizing REMS Re-Enrollment Procedures
This article was originally published in The Pink Sheet Daily
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.
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The agency cited the forthcoming guidance in response to an HHS Inspector General report that questions the effectiveness of the risk management program.
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.
Vivus’ second trip to an advisory panel was a much happier one, with the company’s weight loss therapy garnering an overwhelming “yes” vote on approvability. The key change? A Risk Evaluation & Mitigation Strategy that will be precedent setting if approved—and that demonstrates the power of REMS even if FDA moves in a different direction with this application.