FDA Modernization Act 3.0 marks a major milestone in regulatory science. With the U.S. Senate paving the way for qualified New Approach Methodologies (NAMs), drug development can become more predictive, efficient and human-relevant, DINABIOS welcomes this historic step and stands ready to support the transition from regulation to real-world adoption.

DiNABIOS, a global leader in human‑centric New Approach Methodologies (NAMs) for preclinical research, today celebrates the U.S. Senate’s passage of the FDA Modernization Act 3.0 (FDAMA 3.0), a milestone in modernizing drug development by enabling advanced, human‑relevant nonclinical testing methods.

The Act builds on prior modernization efforts by directing the FDA to establish clear qualification pathways for NAMs, including advanced cell-based, microphysiological and in silico systems. Together, these approaches promise improved predictivity, shorter development timelines and a meaningful reduction in animal testing.

“FDA Modernization Act 3.0 signals a transformative moment for science and industry. Regulatory alignment creates opportunity, but adoption will ultimately be driven by scientific rigor, reproducibility and human relevance – areas where DiNABIOS has made sustained investments.”

Dr. Alexandra Rhoden

CEO of DiNABIOS

“This legislation validates the industry’s shift toward scalable, decision-ready NAM platforms. DiNABIOS is well positioned to support pharmaceutical partners as these methods move into core decision‑making workflows.”

Dr. Marcel Grunert

COO of DiNABIOS

“Modernizing regulatory frameworks is essential for innovation, efficiency and ethical responsibility. This moment underscores the importance of companies that combine scientific excellence with operational readiness – exactly what DiNABIOS represents.”

Reto Wittwer

Chairman of DiNABIOS

About DiNABIOS

DiNABIOS is an innovative life science company improving the predictivity and efficiency of preclinical research from lab to life by integrating advanced experimental and computational systems grounded in human cell and tissue biology.