“For too long, drug manufacturers have performed additional animal testing of drugs that have data in broad human use internationally. This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use,” said FDA Commissioner Martin A. Makary, M.D., M.P.H.
“By leveraging AI-based computational modeling, human organ model-based lab testing, and real-world human data, we can get safer treatments to patients faster and more reliably, while also reducing R&D costs and drug prices. It is a win-win for public health and ethics.”
These are truly great news for everyone who has developed in vitro methods and related tools with such dedication over the past years and decades.
VITROCELL in vitro exposure devices are already widely used for exposing human lung cells in pharmaceutical applications.
The regulatory approach, summarized below, is fully aligned with our objectives and motivation.
It’s definitely a key message from a key regulatory authority.
See the complete news release here: FDA Announces Plan
Join us on LinkedIn to receive the latest highlights of product developments & events.
