As communicated on 17 January 2022, Inhalation Sciences submitted a formal whitepaper to the FDA's National Center for Toxicological Research on how DissolvIt[® ]could further improve research and outcomes for inhaled drugs. The paper proposed a research project aiming to make DissolvIt[®], ISAB's in vitro simulated lung model, FDA-recommended - and ultimately to validate it as a recommended standard research method in inhaled drug development.

ISAB has now received positive feedback on its white paper proposal and has been invited by the FDA panel to submit a full proposal, addressing their specific questions, by June 4, 2022.

ISAB CEO Manoush Masarrat: "This reconfirms the FDA's interest in our unique technology, and its potential to become the FDA-recommended dissolution method in the US. Official endorsement from the FDA would be a huge milestone and transformative for ISAB as well as the industry."

The FDA's National Center for Toxicological Research funds a range of research projects and prioritizes those that "spur the development of new regulatory approaches that can help improve predictability" and "replace, reduce and/or refine animal testing" [(1). ]These are all defining characteristic of DissolvIt[®], ISAB's advanced simulated lung model that produces simulated in vitro dissolution / absorption data that closely predicts in vivo data, with no animal testing involved.

1. https://www.fda.gov/science-research/about-science-research-fda