PDUFA Prompts Crowd-Sourcing Initiative

Source: PhRMA

Nov 08, 2013

Under the Prescription Drug User Fee Act (PDUFA V), Genetic Alliance and the Pharmaceutical Research and Manufacturers of America (PhRMA) will be utilizing a crowd-sourced approach to patient engagement and drug development. This new initiative aims to gain more human insight geared towards patient-focused drug development to tackle the severity and unmet medical needs of certain conditions.

The U.S. Food and Drug Administration (FDA) is dedicated to gaining more patient perspective through public meetings through 2017 under PDUFA.

Genetic Alliance's Platform for Engaging Everyone Responsibly (PEER) will serve as the medium for this new, technology-driven crowd-sourcing approach. Patient communities in specific disease areas--such as sickle cell disease, pulmonary fibrosis, irritable bowl syndrome, gastroparesis and gastroesophagealreflux--will provide input on key benefit-risk issues through PEER.

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