ADVOCACY ALERT! Your Chance to Tell FDA to Give Neuropathy More Attention
October 25th, 2012 

The Food and Drug Administration (FDA) just held a public meeting and announced an opportunity for public comment related to FDA's patient-focused drug development initiative. This initiative is being conducted to fulfill FDA performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). This effort provides for a more systematic approach under PDUFA V for obtaining patient perspective on the disease severity and the currently available treatments for a set of disease areas.

Learn more about PDUFA
and the diseases
nominated for consideration

Tell FDA to give neuropathy
more attention by the
November 1st deadline!

FDA has published a preliminary list of nominated disease areas for the patient-focused drug development initiative and the criteria used for nomination. Included on this list for consideration is peripheral neuropathy. The public is invited to comment on this preliminary list through a public docket where the FDA will provide an overview of the patient-focused drug development initiative with discussion of the nominated disease areas.

In drug regulation, benefit-risk assessment regulatory decision-making includes a thorough understanding of the severity of the treated condition and the adequacy of the existing treatment options.  Patients who live with neuropathy have a direct stake in the outcome of the review process and are in a unique position to contribute to weighing benefit-risk considerations that can occur throughout the medical product development process.

The FDA is committed to getting input from patients.  They want to hear about the impact of the diseases being considered on patients, the range of severity, what matters most to you in getting benefits from treatments, and the adequacy of existing treatments you are using for your neuropathy.  We would encourage loved ones, caregivers, and professionals to respond as well based on your experiences interacting with neuropathy patients.

So let's tell them!  This is a unique and exciting opportunity for every one of us in the neuropathy community to go on record and to directly tell the FDA what you need and how important it is that they select peripheral neuropathy for their list of 20.  Don't miss this chance to advocate for your needs and for the needs of our community. Comment period closes November 1st...speak up and speak out today!

Related Links:

Learn more about PDUFA and the diseases nominated for consideration



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