FDAsafety guidance66% confidence
CDER Streamlined Nonclinical Studies and Acceptable New Approach Methodologies (NAMs)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for pharmaceutical manufacturers; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
It has become increasingly clear that new approach methodologies (NAMs)—when combined with knowledge of the pathway, results of pharmacology studies, and other relevant data—may offer ways to reduce animal testing.
Supporting Context
- Therapeutic area
- Regulatory Affairs · Drug Manufacturing
- Sub-indication
- General
Related signal: FDA Proposes Streamlined Registration for Distributed Drug Manufacturing