PDUFA V Patient-Focused Drug Development

 
Docket ID: FDA-2012-N-0967
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)

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    12/03/2015

      undefined
      • See Attached

      • Public Submission
      • Posted:

        12/16/2015

      • ID:
        FDA-2012-N-0967-0861
      • Organization:
      • Submitter Name:
      • Hello, I'm 56, now, been battling this horrific disease since even before my lobectomy Jan.2013, alittle over 1/2 half of my left lung was removed. was told only hours to live, due...

      • Public Submission
      • Posted:

        12/16/2015

      • ID:
        FDA-2012-N-0967-0860
      • Organization:
      • Submitter Name:
      • There are a few things that I feel could be very helpful to NTM patients: 1. Skin test for NTM. If there is a skin test for TB, why is there not one for NTM? Perhaps several for...

      • Public Submission
      • Posted:

        12/16/2015

      • ID:
        FDA-2012-N-0967-0859
      • Organization:
      • Submitter Name:
      • Docket No. FDA-2012-N-0967 My comments will address current treatment approaches from the perspective of a patient with pulmonary NTM (PNTM). I was diagnosed with MAC and...

      • Public Submission
      • Posted:

        12/16/2015

      • ID:
        FDA-2012-N-0967-0858
      • Organization:
      • Submitter Name:
      • I previously submitted a questionnaire, but since that time have experienced some health setbacks. Please allow me to submit this additional comment. Having taken three macrolides...

      • Public Submission
      • Posted:

        12/16/2015

      • ID:
        FDA-2012-N-0967-0857
      • Organization:
      • Submitter Name:
      undefined
      • Attached

      • Public Submission
      • Posted:

        12/16/2015

      • ID:
        FDA-2012-N-0967-0856
      • Organization:
      • Submitter Name:
      undefined
      • Attached

      • Public Submission
      • Posted:

        12/16/2015

      • ID:
        FDA-2012-N-0967-0855
      • Organization:
      • Submitter Name:
      • Someone else might have noticed, but it seems to me that the webinar's forced-choice question on comorbidity generated poor data because it selected out patients who had NTM...

      • Public Submission
      • Posted:

        12/16/2015

      • ID:
        FDA-2012-N-0967-0854
      • Organization:
      • Submitter Name:
      • Topic 1 1. Chronic cough, increased sputum production, shortness of breath. 2. Exercising, sleeping through the night. On my worst days, I cough up a lot of sputum, feel short of...

      • Public Submission
      • Posted:

        12/16/2015

      • ID:
        FDA-2012-N-0967-0853
      • Organization:
      • Submitter Name:
      undefined
      • See attached

      • Public Submission
      • Posted:

        12/16/2015

      • ID:
        FDA-2012-N-0967-0852
      • Organization:
      • Submitter Name:
      undefined
      • Attached are comments submitted by the children of the co-founders of NTM Info & Research, the patient advocacy organization for nontuberculous mycobacterial lung disease.

      • Public Submission
      • Posted:

        12/16/2015

      • ID:
        FDA-2012-N-0967-0851
      • Organization:
      • Submitter Name:
      undefined
      • Attached is the full text of the Comment submitted on behalf of NTM Info & Research, along with two appendices aggregating comments from more than two dozen patients. All three...

      • Public Submission
      • Posted:

        12/16/2015

      • ID:
        FDA-2012-N-0967-0850
      • Organization:
      • Submitter Name:
      undefined
      • Please see attached.

      • Public Submission
      • Posted:

        12/16/2015

      • ID:
        FDA-2012-N-0967-0849
      • Organization:
      • Submitter Name:
      undefined
      • I've watched my mom steadily decline over the past 8 years as Huntington's disease has stripped her more and more of her ability to think, move, and express herself. The kind...

      • Public Submission
      • Posted:

        12/04/2015

      • ID:
        FDA-2012-N-0967-0848
      • Organization:
      • Submitter Name:
      • Twelve years ago I began working as a representative in the biotech industry in the disease state of Multiple Sclerosis (MS). When I first started there were two types of...

      • Public Submission
      • Posted:

        12/04/2015

      • ID:
        FDA-2012-N-0967-0847
      • Organization:
      • Submitter Name:
      undefined
      • I am Jane mother widow and caregiver to my family.My husband passed away at age of 48, nine weeks prior, our youngest daughter Karli,only 13 yrs old,passed away.They died of...

      • Public Submission
      • Posted:

        12/04/2015

      • ID:
        FDA-2012-N-0967-0846
      • Organization:
      • Submitter Name:
      • It's time that the FDA begins Fast tracking approval for therapies for HD! These patients are dying. They have no therapies. These studies need to be tested on humans sooner not...

      • Public Submission
      • Posted:

        12/04/2015

      • ID:
        FDA-2012-N-0967-0845
      • Organization:
      • Submitter Name:
      • Huntington's disease has been in my family on my mother's side since my grandmother's grandmother as far as we can tell. My first memory is of my mother having seizures on the...

      • Public Submission
      • Posted:

        12/04/2015

      • ID:
        FDA-2012-N-0967-0844
      • Organization:
      • Submitter Name:
      • Huntington's Disease affects so many people. More funding and research is desperately needed. We must find a way to better treat it. Huntington's affects not only the person...

      • Public Submission
      • Posted:

        12/04/2015

      • ID:
        FDA-2012-N-0967-0843
      • Organization:
      • Submitter Name:
      • Huntington's Disease has not had nearly enough attention and research. It is such a terrible disease and affects someone I love.

      • Public Submission
      • Posted:

        12/04/2015

      • ID:
        FDA-2012-N-0967-0842
      • Organization:
      • Submitter Name:
      • Unfortunately HD has been an illness in my family for generations. I innocently thought HD only had negative effects on the individuals affected. Until my at-risk sister killed an...

      • Public Submission
      • Posted:

        12/04/2015

      • ID:
        FDA-2012-N-0967-0841
      • Organization:
      • Submitter Name:
      • People with HD need hope through treatment. As of now, it is a death sentence to have this horrific disease. Please fast-track therapies for HD so people can at least have a chance...

      • Public Submission
      • Posted:

        12/04/2015

      • ID:
        FDA-2012-N-0967-0840
      • Organization:
      • Submitter Name:
      • My Uncle died of Huntington's Disease. While his chorea was unsettling, his mental personality changes were the most disturbing. From a successful CPA and business owner to a quasi...

      • Public Submission
      • Posted:

        12/04/2015

      • ID:
        FDA-2012-N-0967-0839
      • Organization:
      • Submitter Name:
      • My brother in law passed away from Huntington's Disease in 2003. At the time of his diagnosis in 1990 he thought that there would be a cure or treatment in his lifetime but that...

      • Public Submission
      • Posted:

        12/04/2015

      • ID:
        FDA-2012-N-0967-0838
      • Organization:
      • Submitter Name:
      • Dear FDA officials, I am writing to tell you about my brother-in-law, Tim, who was diagnosed with Huntington's Disease when he was ~ 40 years old. Up until Tim was diagnosed...

      • Public Submission
      • Posted:

        12/04/2015

      • ID:
        FDA-2012-N-0967-0837
      • Organization:
      • Submitter Name:
      • To Whom It May Concern: My name is James Valvano and I am the founder and president of WeHaveAFace.org Inc - a 501(c)(3) nonprofit organization based out of Saint Cloud, Florida...

      • Public Submission
      • Posted:

        12/04/2015

      • ID:
        FDA-2012-N-0967-0836
      • Organization:
      • Submitter Name:
      • Please speed up approvals for clinical trials for Huntingtons Disease.

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0835
      • Organization:
      • Submitter Name:
      • My fiance has Huntington's Disease. His Mom passed away in 2006 due to complications of Huntington's Disease. We have started a nonprofit organization to help those whose lives are...

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0834
      • Organization:
      • Submitter Name:
      • Every step of the way with the FDA we need an HD volunteer patient/family representative to be present. No decision should be made about us - without us! The FDA can never know...

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0833
      • Organization:
      • Submitter Name:
      • This testimony is about my husband Tim: dx. age 39; died age 51. HD blood test confirmed HD in 1995. Tim's mother and older brother both had HD with the characteristic chorea and...

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0832
      • Organization:
      • Submitter Name:
      • My wife Amanda was diagnosed with Huntingtons Disease 6 years ago. Early symptoms were memory loss while at work. In one terrible day Amanda was diagnosed with huntingtons...

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0831
      • Organization:
      • Submitter Name:
      • I am gene positive for HD. I had genetic testing done in 2011, and I am so afraid of losing all of my capacities one by one after watching what happened to my mother. I am only...

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0830
      • Organization:
      • Submitter Name:
      • In my last comment, I was discussing the worst symptoms for HD, both for the individual and the family and emphasizing how psychiatric symptoms cause extreme disruption and pain...

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0829
      • Organization:
      • Submitter Name:
      • The worst part about my mom's symptoms was how it changed her personality and turned the person who we knew and loved into someone else. She was a really kind, compassionate...

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0828
      • Organization:
      • Submitter Name:
      • I am writing for my husband who has Huntington's disease. I have noticed for many years a change in his personality and degrade of some of his cognitive ability. When we found out...

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0827
      • Organization:
      • Submitter Name:
      • B. Huntington's Disease Discussion Questions Topic 1: Disease Symptoms and Daily Impacts That Matter Most to Patients 1. Of all the symptoms that you experience because of your...

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0826
      • Organization:
      • Submitter Name:
      undefined
      • "See attached letter submitted by ACADIA Pharmaceuticals for the Public Meeting on Patient-Focused Drug Development for Parkinson's Disease "

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0825
      • Organization:
      • Submitter Name:
      • Symptoms in Huntington's disease begin earlier than most families realize, because symptoms may be initially subtle and appear seemingly sporadically, but over years with...

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0824
      • Organization:
      • Submitter Name:
      • As a person who knows what it's like to watch my wife and two brothers in law suffer from Huntington's disease, I hope you can do all that is possible to help these pore people...

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0823
      • Organization:
      • Submitter Name:
      • I want to first extend my gratitude to the FDA for engaging in this analysis. As you know, Huntington's Disease is a catastrophic illness that comprehensively destroys entire...

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0822
      • Organization:
      • Submitter Name:
      • It is my hope that you will consider the lives of those effected by Huntington's disease as you make decisions involving their medical care,specifically the drugs that may be able...

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0821
      • Organization:
      • Submitter Name:
      • I have known about Huntington's since my grandmother was diagnosed in the late 1950's. She died by choking to death. My father also died by choking. My brother died because his...

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0820
      • Organization:
      • Submitter Name:
      • Hello, Thank you for the opportunity to comment on this important quality of life issue facing far too many Americans and people of the world. While I am not directly involved in...

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0819
      • Organization:
      • Submitter Name:
      undefined
      • See attached file(s)

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0818
      • Organization:
      • Submitter Name:
      • I attended the Public Meeting on Patient-Focused Drug Development for Huntington's and Parkinson's Diseases as a family member of persons with these illnesses. My father died...

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0817
      • Organization:
      • Submitter Name:
      • Huntington's Disease has devastated this family for at least the past 5 generations that we have been able to track. It doesn't just maim and kill an individual it destroys...

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0816
      • Organization:
      • Submitter Name:
      • I am a physician by training, and a former husband (now widower) of the Huntington Disease patient, whose beautiful, productive in all measures life was interrupted almost 25...

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0815
      • Organization:
      • Submitter Name:
      • As a caregiver for three family members suffering from Huntington's disease, I have seen firsthand how the cognitive decline, especially with regard to executive function...

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0814
      • Organization:
      • Submitter Name:
      • People who have never been affected by Huntington's have no CLUE at the difficulties the families that have face. The disease has left me with no family and alone, let some of you...

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0813
      • Organization:
      • Submitter Name:
      • Please help with a cure for huntington's disease. Myself, my family and others need it so much! Thank you!

      • Public Submission
      • Posted:

        12/03/2015

      • ID:
        FDA-2012-N-0967-0812
      • Organization:
      • Submitter Name:
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