dieoDate: September 26, 2014
Time: 1:00 a.m. to 5:00 p.m.
Location: FDA White Oak Campus
10903 New Hampshire Ave.
Building 31 Conference Center, The Great Room (Rm 1503)
Silver Spring, MD 20993
On September 26, 2014, FDA is conducting a public meeting on Idiopathic Pulmonary Fibrosis Patient-Focused Drug Development. FDA is interested in obtaining patient input on symptoms and daily impacts that matter most to patients (topic 1), and current available approaches to treat idiopathic pulmonary fibrosis (topic 2). The questions for discussion on these topics are below.
For each of these topics, a panel of patients and patient representatives/advocates will present comments to begin the dialogue and will be followed by a facilitated discussion inviting comments from all patients and patient representatives in the audience.
If you are interested in providing comments as part of the initial panel discussion, indicate so during the registration process. Panelists will be confirmed prior to the meeting.
There will also be an opportunity for patients, patient representatives and others to provide comments on issues other than topics 1 and 2 during an Open Public Comment session. Sign up for Open Public Comment will take place the day of the meeting.
Webcast participants will also have an opportunity to provide input through webcast comments.
For more information, refer to the FDA meeting website at: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm395774.htm
Questions for Discussion
Topic 1: Disease signs, symptoms and daily impacts that matter most to patients
1) Of all the symptoms that you experience because of the condition, which 1-3 symptoms have the most significant impact on your life? (Examples may include shortness of breath, cough, fatigue, 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 household chores, walking up the stairs, etc.)
a) How do your symptoms and their negative impacts affect your daily life on the best days? On the worst days?
3) How has your condition and its symptoms changed over time?
Topic 2: Patient perspectives on current approaches to treating idiopathic pulmonary fibrosis
1) What are you currently doing to help treat the condition or its symptoms? (Examples may include prescription medicines, over-the-counter products, and other therapies including non-drug therapies such as diet modification.)
a) How well does your current treatment regimen treat the most significant symptoms of your disease?
2) What are the most significant downsides to your current treatments and how do they affect your daily life? (Examples of downsides may include bothersome side effects, going to the hospital for treatment, etc.)
3) Because there is no complete cure for your condition, what specific things would you look for in an ideal treatment for your condition?