CDER adopts streamlined nonclinical research and New Approach Methods (NAMs)
Background and Rationale
The FDA CDER is exploring ways to reduce animal testing in nonclinical research by leveraging New Approach Methods (NAMs). NAMs integrate pathway knowledge, pharmacology research results, and other relevant data.
Core Principles of NAMs
NAMs include non‑animal technologies such as in‑silico modeling and organ‑on‑a‑chip, which reflect human biological pathways to improve predictive accuracy. The FDA permits review of these data alongside traditional pharmacokinetic and pharmacodynamic information.
Anticipated Benefits
By replacing animal experiments, costs and timelines can be reduced, and ethical concerns can be mitigated. This is expected to have a positive impact on biopharma development strategies.
The adoption of NAMs is likely to lower animal testing costs and shorten development timelines, thereby improving return on investment. Demand is growing for talent with expertise in emerging non‑animal technologies, making it advantageous for career development.