Monthly Archives: November 2014

Will the FDA Listen to the Lupus Community? It’s up to You!

The Food and Drug Administration is about to embark on a project to get patients’ take on chronic illnesses, and lupus is not (yet) on the list! But you can change that. The following is an appeal LFNC is actively joining as part of the Lupus Research Institute National Coalition.

The FDA is currently inviting public comment on what disease areas it should include in public meetings to be held in the next couple of years. So let’s get lupus included!

We’re urging everyone to write to the FDA about why lupus must be included.

Please hurry; you need to respond by December 5.

What You Need To Do (click here for sample letter):
Use the outline below as a guideline to write your own letter, in your own words.
The FDA is using four criteria to determine what conditions it will hold meetings about. In your letter, please describe your own situation or that of a loved one to illustrate how lupus meets the following 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).
Must include that you are responding to Docket No. FDA-2012-N-0967.
Submit electronically using this link.  Or, mail your letter to: Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852
Once again, a sample letter is available here. Please let us know that you have contacted the FDA by replying to this post.


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