Functional respiratory imaging (FRI) specialist Fluidda has requested a Critical Path Innovation Meeting (CPIM) with the FDA as part of an initiative for approval of its FRI technology as a biomarker, the company said.
According to Fluidda CEO Jan de Backer, the company will use the CPIM to bring the FDA up to date on development and validation of FRI, which the company says “enables researcher to assess the efficacy of drugs in a smaller number of patients which allowing for faster and cheaper drug development thereby opening up a pathway towards more, better and cheaper drugs for patients with high unmet medical needs.”
Submissions of separate briefing packages for COPD, idiopathic pulmonary fibrosis (IPF), lung transplantation, and bioequivalence are planned for the 3rd and 4th quarters of this year.
Read the Fluidda announcement.
