FDAsafety guidance72% confidence
BsUFA II: Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (cardiology) as Merck.
Regulatory Analysis
Over the years, FDA has worked to increase communication between Agency staff and applicants during the review of novel drug and original biologic applications. The goal has been to enhance the transparency, predictability, effectiveness, and efficiency of the review process.
Supporting Context
- Therapeutic area
- Cardiology · LDL-C Lowering
- Sub-indication
- Hypertension
Related signal: Merck's Enlicitide Study Aims to Enhance LDL-C Reduction with Rosuvastatin