The FDA is asking the Coalition for Pulmonary Fibrosis to inform you about an important workshop on Idiopathic Pulmonary Fibrosis (IPF) that will be held Friday, September 26th. It's a meeting we told you would be coming! To sign up, go to: http://patientfocusedipf.eventbrite.com.
It is the first meeting of its kind to be held on IPF with a focus on patients and the patient community. You can join the meeting at the FDA offices in Silver Spring, MD or you can join via webinar online. But you must act quickly to reserve your seat since space is limited. To register for either the in-person meeting or the online meeting, go to: http://patientfocusedipf.eventbrite.com. If you cannot join either way, you can submit your comments online or by snail mail to FDA via an opportunity through the public docket to be announced by FDA. Check with the FDA on the status of that opportunity by going to the FDA Website: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm395774.htm.
The PF community recently joined together in a request that the FDA include the disease in an important series of workshops mandated by Congress.
Details from the FDA:
We invite you to attend an upcoming public meeting on idiopathic pulmonary fibrosis,as part of FDA’s Patient-Focused Drug Development initiative. The goal of the meeting is to hear patient perspectives on symptoms of idiopathic pulmonary fibrosis that matter most to them and on current approaches to treating idiopathic pulmonary fibrosis.
Meeting Information
Date: September 26, 2014
Time: 1:00 pm – 5:00 pm
Location: FDA White Oak campus at 10903 New Hampshire Avenue, Silver Spring, MD
Attendees can register here: http://patientfocusedipf.eventbrite.com. Remote access will be available via live webcast for those unable to attend in person. Patient representatives, such as caretakers or leaders of support groups, are also welcome to attend and share their perspectives. A public docket will also be available, which will give patients an opportunity to submit comments to FDA online or through the mail.
For more information, visit the FDA website:
Background on the inclusion of IPF in this important FDA initiative and the CPF's member involvement:
Thanks to you and every member of the PF patient community, including advocacy groups, patients, family members, caregivers and medical professionals, PF is part of the initiative, even though it wasn't on the preliminary FDA list! More than 2,000 CPF members sent letters to the FDA to Commissioner Margaret Hamburg and she and the entire FDA heard them. The Coalition for Pulmonary Fibrosis spoke for members of the PF community at a key FDA meeting in October 2012 to ask that PF be included in the important new program at the FDA that includes patient input in the process of drug development.
This new drug development program resulted from the Prescription Drug User Fee Act passed by Congress.
Also, PF Champions in Congress, Senator Christopher Coons (D-DE) and Erik Paulsen (R-MN) wrote a letter to FDA's commissioner, Margaret Hamburg asking her to include PF in the program.
The CPF remains committed to advocating for patients and families fighting PF and we look forward to working with the FDA on the IPF Workshop.
If you'd like to support our efforts to raise awareness for PF, you may make a tax-deductible contribution by clicking here.
For further details on the content of the FDA workshop, see the bottom of this email.
Sincerely,
Mishka Michon, CEO of the Coalition for Pulmonary Fibrosis
Important Details about the Workshop Itself from the FDA:
Description
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.
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 chorse, 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 currenty 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 diease?
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?
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