FDAsafety guidance83% confidence
Data Standards Program Strategic Plan and Board
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Eli Lilly.
Regulatory Analysis
The Data Standards Strategy reinforces CDER’s ongoing commitment to the development, implementation, and maintenance of a comprehensive data standards program that will facilitate the efficient and effective review of regulatory submissions. This helps bring safe and effective products to market.
Supporting Context
- Therapeutic area
- Infectious Disease · Viral and Bacterial Pathogens
- Sub-indication
- General
Related signal: Lilly expands infectious disease portfolio with three strategic acquisitions