FDAsafety guidance65% confidence
S6 (R1) Addendum: Preclinical Safety Evaluation of Biotechnology - Derived Pharmaceuticals
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (cardiology) as Torrent Pharmaceuticals.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Cardiology · Heart Failure
- Sub-indication
- Hypertension
Related signal: Torrent Pharmaceuticals submits ANDA for Vericiguat