Cell based assays in regulatory submissions

FDA modernization bill

FDA Modernization Act 2.0, S.5002

The US Senate has passed the FDA Modernization Act 2.0, S.5002. This allows nonclinical tests such as cell-based assays, micro physiological systems, or bioprinted or computer models to be used and can include methods such as human iPSC derived cells.

“To allow for alternatives to animal testing for purposes of drug and biological product applications.”

In vivo models have been the standard for testing for decades. 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.Famously, mice don’t get Alzheimer’s. The passing of this bill opens the regulatory window for non animal regulatory data to be submitted including cell assays and data driven approaches.

On the search for better models for human disease

The FDA Modernization Act is a strong signal for change, encouraging and enabling drug discovery to invest in novel, non-animal, more human models.