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Sidley says it published an analysis of FDA’s rare disease framework initiative
Sidley said it published an analysis of FDA’s Rare Disease Framework Initiative and its potential approach to reviewing rare disease therapies. The firm’s update examines cross-center consistency, evidentiary standards and opportunities for public input, while distinguishing possible regulatory changes from measures with a specified implementation timeline.
Key points
- The firm’s article discusses small patient populations and limited natural-history data.Sidley
- Sidley’s analysis distinguishes rulemaking from updates to guidance and internal review processes.Sidley
- The firm’s publication identifies an October 28 public meeting as an opportunity for input.Sidley
- Sidley lists Rebecca Wood, Emily Marden, Kelly Cho and Monica Kofron as contacts for the update.Sidley