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Re: XenaLives post# 124087

Thursday, 10/12/2017 8:06:56 AM

Thursday, October 12, 2017 8:06:56 AM

Post# of 459752
Falconer, Xena...we called it...read on...what a concept...ASK THEM HOW THEY FEEL. IMO, todays PR/NEWS on AD was held until FDA speaks about process...now all hands...general quarters...THIS IS NOT A DRILL

The Food and Drug Administration is hosting a pioneering event today: the first meeting of the Patient Engagement Advisory Committee or PEAC. It’s a significant step forward in the FDA’s efforts to broaden its engagement with patients – and to deepen the involvement of patients in our regulatory activities.
This is the agency’s first advisory committee that’s comprised solely of patients, care-partners, and those who represent their needs. Founded by the FDA’s Center for Devices and Radiological Health (CDRH), it reflects CDRH’s commitment to keep patients at the center of their work.
The FDA’s work requires us to establish objective, consistent criteria on which we base our decisions. But ultimately, the criteria we use to judge benefit and risk turn on the parameters that matter to patients.
Involving the end-user – the patient – in identifying health priorities and outcomes desired from health interventions is critically important.
This requires cultures and processes that ensure routine integration of these patient perspectives at each key stage of product development.



https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm579842.htm
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