FDA updates regulations to permit non-animal drug safety testing
The U.S. Food and Drug Administration issued a direct final rule that replaces the term “animal tests” with “nonclinical tests,” opening pathways for non‑animal methods in drug and biologic safety assessment. VivoSim Labs, which provides 3‑dimensional human liver and intestinal cell models, said the change supports broader use of its New Approach Methodologies. Executive Chairman Keith Murphy noted that earlier detection of toxic compounds could spare companies from incurring costs of $50 million to $200 million on candidates that later fail in clinical trials. VivoSim expects the regulatory shift to accelerate adoption of its human‑tissue models.
Why it matters
The company says the new rule should speed up uptake of its NAM models, potentially expanding its contract research revenue (the company expects). The regulatory clarification also reduces barriers for pharmaceutical firms to use human‑relevant testing, which could increase demand for VivoSim’s services.
Key facts
- 1The FDA issued a direct final rule updating its regulations to allow non‑animal methods for safety testing of drugs and biologics. globenewswire.com
- 2The rule replaces the term "animal tests" with "nonclinical tests" across the agency’s framework. globenewswire.com
- 3Keith Murphy said early identification could prevent companies from incurring costs of $50 million to $200 million on drug candidates that later fail in clinical trials. globenewswire.com
- 4VivoSim expects accelerated adoption of its human tissue models following the FDA roadmap. globenewswire.com
- 5The company’s liver tissue models can flag drug candidates likely to cause liver toxicity and gastrointestinal side effects. globenewswire.com
- 6VIVS shares closed at $0.20, down 2.18%, and were up 2.03% in pre‑market trading at $0.20. rttnews.com
Summary written by AlphAI from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.