Friday, December 9, 2016

EPP Online docket Question's for FDA

Following the FDA meeting for EPP that was held in October, the FDA opened an online public docket for EPP people to submit comments.  This docket is open to attendees of the meeting AND those that were unable to attend in person.  The FDA is particularly interested in hearing patients' perspectives on the questions discussed during the workshop.  These questions are pasted below for your reference.  If you have any questions, please email meghana.chalasani@fda.hhs.gov.

Comments MUST be submitted by December 24, 2016.  Submit your comments through this website: 

The FDA has also posted a full recording of the EPP meeting.  You may view the recording here: 



Discussion Questions

1.  Of all the symptoms that you experience because of your condition, which 1-3 symptoms have the most significant impact on your daily life? (Examples may include itching, burning, pain, scarring, etc.)
2.   Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your condition? (Examples of activities may include daily hygiene, work and school performance, participation in sports or social activities, etc.)
3.    How have your condition and its symptoms changed over time?
4.   What are you currently doing to manage your condition or its symptoms? (Examples may include prescription medicines, phototherapy, over-the-counter products, and other therapies including non-drug therapies such as limiting exposure to sun, diet modification, etc.)
a.     What specific symptoms do your therapies address?
b.    How has your treatment regimen changed over time, and why?
5.    How well does your current treatment regimen control your condition?
a.     Would you define your condition today as being well managed?
6.    Assuming there is no complete cure for your condition, what specific things would you look for in an ideal treatment for your condition?
a.   What would you consider to be a meaningful improvement in your condition (for example specific symptom improvements) that a treatment could provide?







"Remember....Research is the key to your cure!"



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