The FDA Modernization Act 2.0’s approval is a significant milestone for the organ-on-chip market and is likely to accelerate the advancement and uptake of these cutting-edge technologies in the pharma industry.
FDA Modernization Act 2.0 approval accelerates adoption of organ-on-chip technology in pharma, leading to more effective & safer drugs for humans & personalized medicine.
The FDA Modernization Act 2.0 amends the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and clarifies the procedures manufacturers and sponsors can use to investigate the safety and efficacy of a drug, including the possibility to use “advanced technologies” such as:
- Cell-based assays
- Organ chips and microphysiological systems
- Sophisticated computer modelling
- Other human biology-based test methods
This significant law opens the door for the adoption of new alternative methodologies that accurately represent human biology, such as 3D in vitro models and organ-on-chip technologies.
Organ-on-chip systems are microphysiological systems that mimic the structure and function of human organs, such as the lung, heart, and liver. These systems are being developed as alternatives to traditional animal testing and provide a more accurate and efficient way to predict the safety and efficacy of drugs and molecules.
The approval of the FDA Modernization Act 2.0 is a major step forward for the organ-on-chip industry and is expected to accelerate the development and adoption of these advanced technologies in the pharmaceutical industry. This bill includes provisions to facilitate the development and use of organ-on-chip systems in drug development and safety testing, as well as provisions to support the development of new organ-on-chip systems for other applications.
The FDA Modernization Act 2.0 does not eliminate the use of animal testing for drugs, nor does it suggest that animal testing is no longer necessary. Rather, it amends the definition of nonclinical testing or studies under the Food, Drug and Cosmetics Act to encompass methods such as organ-on-a-chip systems, micro-physiological systems and computer simulations as additional or complementary testing options.
Anyhow, this new law, revamping the drug approval process, will lead to a significant decrease in the use of dogs, primates, and other animals in laboratory studies, towards more innovative, predictive and reliable tests.
In conclusion, the FDA Modernization Act 2.0 is a significant step forward for the organ-on-chip industry and the pharmaceutical industry. It will facilitate the development and use of organ-on-chip systems in drug development and safety testing, ultimately leading to the development of more effective and safer drugs for humans.
Also, the possibility to test drugs with organ-on-chip systems can reduce the risk of drug development failure and the time it takes for drugs to reach the market, for faster access to new treatments for patients and a significant reduction of the cost of development for pharmaceutical companies.