The Importance of Quality Activities to REMS Success
Most manufacturers learn FDA wants a REMS during application review, so audit and noncompliance planning gets pushed past approval. The gaps surface in assessment reports and FDA inspections, and fixing them can require a formal REMS modification.
What’s inside:
Prevent technicality-driven findings. Design workflows so pharmacies and healthcare settings can document training and demonstrate compliance.
Make audits consistent. See what Shepherd's research with CAR-T treatment sites revealed about auditor judgment, and how to limit it.
Avoid false noncompliance flags. Choose compliance data sources before pharmacy contracts and system requirements are locked.
Lower remediation costs. See why outbound re-education calls fall short and how technology-based remediation can reduce cost and stakeholder burden.
