Tag Archives: FDA

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.

FLUIDDA to present and exhibit at the IPF Summit in Boston, 21-23 Aug 2017

FLUIDDA’s CEO Dr. Jan De Backer will present at IPF Summit in Boston next month. Dr De Backer will discuss how using Functional Respiratory Imaging (FRI) in clinical trials has led to valuable insights into disease progression and treatment effects. Furthermore, the use of FRI, as an FDA supported drug development tool, will be discussed.… Continue Reading

Fluidda NV

Groeningenlei 132

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Belgium

BE 0877 160 706

Tel: +32/(0)3 450 87 20

Fax: +32/(0)3 450 87 29

info@fluidda.com

Fluidda NV

Groeningenlei 132

2550 Kontich

Belgium

BE 0877 160 706

Tel: +32/(0)3 450 87 20

Fax: +32/(0)3 450 87 29

info@fluidda.com

FLUIDDA, Inc

675 US Highway One
North Brunswick, NJ 08902
United States

FLUIDDA, Inc

675 US Highway One
North Brunswick, NJ 08902
United States

FLUIDDA India

Medical Imaging pvt ltd
A-95/96, DGP Nagar -2, Ambad
Nashik 422010
India

FLUIDDA India

Medical Imaging pvt ltd
A-95/96, DGP Nagar -2, Ambad
Nashik 422010
India

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