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The FDA Modernization Act is huge!

The FDA Modernization Act is huge!


FDA Modernization Act 2.0, S.5002 News

In case you didn’t know, the US Senate just passed the FDA Modernization Act 2.0, S.5002. If enacted, this would allow for nonclinical tests such as cell-based assays, microphysiological systems, or bioprinted or computer models to be used and can include methods such as human iPSC derived cells.

In vivo models have been the standard for testing for decades and while they do offer a great deal of information, they take a high toll on animal life – animals that often lack significant similarities to human physiology. The effort scientists have put into tweaking and humanizing animal models for more accurate results, can now justifiably be redirected to improving in vitro models.

The move away from animal for testing, and towards animal-free in vitro models is a game changer for drug development and research in general. We think research should strive to embrace more modern techniques, like the use of human iPSC-derived cells.

In vitro, coupled with in silico work, not only spares countless animal lives, but could deliver more accurate, more reliable results in understanding drugs and disease.


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Jan Turner

Axol Bioscience


About Axol Bioscience

Axol is a leading provider of product and service solutions in the iPSC-based neuroscience, immune cell, and cardiac modeling for drug discovery and screening markets. Our custom research capabilities in gene editing, electrophysiology, reprogramming, and differentiation means we can offer customers validated ready-to-use cell lines and a suite of services bolstered by deep scientific expertise and robust functional data – all with shorter lead times. To find out more, visit axolbio.com.

On-Demand Webinar: “CiPA Validation of hiPSC-Derived Cardiomyocytes for Drug Safety Evaluation” – June 9th
Cardiomyocytes from human iPSCs are valuable tools to assess non-clinical cardiotoxicity