Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of ...
3月18日,FDA发布《药物开发中使用新方法学的一般考虑》行业指南草案。该指南旨在为药物研发者提供一个关于新方法学(New Approach Methodologies, NAM)的验证框架,进而优化对人体毒性的预测,并逐步减少对动物试验的依赖。
March 18 (Reuters) - The U.S. Food and Drug Administration on Wednesday issued a draft guidance to help companies reduce ...
The guidance clarifies what sponsors should consider when putting together an application for the validation of a NAM ...
Health authorities in the U.S. are continuing their move away from animal testing in drug development, with the FDA signaling ...
The FDA has released draft guidance aimed at helping drug developers shift away from traditional animal testing as the ...
In other developments, the EPA updated emission standards for polyether polyols and declined to regulate 9 drinking-water ...
As regulatory authorities accelerate the use of New Approach Methodologies (NAMs), the drug discovery landscape is changing dramatically. This webinar explores how NAMs, immunology-driven platforms, ...
In what the U.S. FDA has dubbed a milestone move toward fewer animal studies in drug development, the agency published a ...
DiNABIOS Applauds Historic U.S. Senate Passage of FDA Modernization Act 3.0, Advancing Human‑Relevant New Approach Methodologies (NAMs) ZURICH/SCHLIEREN, Switzerland, December 24, 2025 – DiNABIOS AG, ...