Speak up for Lupus with the Food and Drug Administration The Food and Drug Administration (FDA) has launched its Patient-Focused Drug Development Initiative, and they need your input. Through this effort, the FDA is looking to gather patient and caregiver perspective on disease severity and available treatments for a set of disease areas for consideration in future patient-focused drug development meetings. Lupus is not currently on the preliminary list of nominated diseases, but there is something you can do to help get it included. The public is invited to comment through a public docket on the preliminary list of nominated disease areas. As someone with personal experience with lupus - whether as a patient, caregiver, or touched by the disease in some way – your feedback is important. The FDA requests that you provide comments addressing the following key criteria: • Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living; • Disease areas for which aspects of the disease are not formally captured in clinical trials; • Disease areas for which there are currently no therapies or very few therapies, or the available therapies do not directly affect how a patient feels, functions, or survives; and • Disease areas that have a severe impact on identifiable subpopulations (such as children or the elderly). **You may submit either electronic or written comments by December 5, 2014. All comments should be identified with the Docket No. FDA–2012–N–0967.** Submit electronic comments to: regulations.gov. More information: bit.ly/FDAPFD
Posted on: Mon, 24 Nov 2014 22:07:32 +0000
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