FDAsafety guidance66% confidence
Over-The-Counter Monograph Drug User Fee Program (OMUFA)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for TRAVERE; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
A user fee program for nonprescription (over-the-counter or OTC) monograph drugs would be a potential funding mechanism to supplement congressional non user-fee appropriations.
Supporting Context
- Therapeutic area
- Nephrology · SGLT2 Inhibitor
- Sub-indication
- General
Related signal: FDA Accepts Supplement for FILSPARI (SPARSENTAN) by TRAVERE
Source
FDA document
View source