FLUIDDA steps up FDA biomarker approval initiatives

In line with FDA commissioner’s, Dr Gottlieb, latest blog, FLUIDDA launched a comprehensive FDA Biomarker Approval initiative focusing on Idiopathic Pulmonary Fibrosis (#IPF), Chronic Obstructive Pulmonary Disease (#COPD), Bio-equivalence (#BE) and Lung Transplantation.

As part of FDA’s critical path initiative FLUIDDA plans to submit several files demonstrating the added value of its Functional Respiratory Imaging (FRI) technology as a drug development tool. FRI is a combination of CT imaging, in-silico methods and artificial intelligence and provides highly accurate regional information about lung structure and function. FRI 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.

FLUIDDA submitted a request for a Critical Patch Innovation Meeting to the agency last week. During this meeting the company plans to update FDA on the latest development, validation and applications of FRI. Later in Q3 and Q4 FLUIDDA plans to submit individual briefing packages for IPF, COPD, Bio-equivalence and Lung Transplantation.

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