Friday, April 19, 2013

FDA Pilot Project to Focus on PAH



In October, PH patient and PHA Board Member, Colleen Brunetti, represented the PH community before the Food and Drug Administration (FDA). In her testimony, Colleen argued for the inclusion of PAH in FDA’s new patient focused drug development initiative.

The goal of this initiative is to engage those living with a wide variety of diseases in giving input to the FDA about how the drug and device approval processes can be adapted to better meet patients’ needs. For example, FDA will seek input on the way they assess risk versus benefit during the approval process for new drugs and devices.

FDA selected 20 disease communities to work with over the next three years and the PAH community is one of them! Several diseases associated with PAH are also among the twenty selected including sickle cell, HIV and idiopathic pulmonary fibrosis.

PHA plans to use this opportunity to build a long-term, collaborative relationship with FDA that will benefit the entire PH community well beyond the term of the initial project. We look forward to updating you as we learn more.

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