Public Meeting on Functional GI Disorders Patient-Focused Drug Development

Public Meeting on Functional GI Disorders Patient-Focused Drug Development

The FDA meeting for gastroparesis as part of their Patient Focused Drug
Development program has been scheduled for Monday May 11th from 1:00 –
5:00 PM.  Anyone who can attend, should.

For more info: www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm430885.htm

One thought on “Public Meeting on Functional GI Disorders Patient-Focused Drug Development

  1. Please bear with me because this is a lengthy response; however, it contains very valuable information for the FDA Panel Discussion. Many people (including me) wanted to know if they could submit questions without being present for the discussion. I wrote the event organizer to find out. My question and her response follow:
    ******************************************************************
    Dear FDA Panel Organizer,
    In reference to the “Functional GI Disorders Patient-Focused Drug Development Public Meeting” scheduled for May 11, 2015, from 1:00-5:00 PM, I was wondering if it would be permissible to submit written comments and answers to the “Questions for Discussion” that were posted without actually serving (in-person) on the panel. Many of us who suffer from gastroparesis are simply too ill to attend the meeting, and it is cost prohibitive as well; yet, we would dearly love for you to see our answers to your panel questions. Would you allow us to submit written answers without being physically present for the panel discussion?
    Thank you for your consideration!
    Melissa VanHouten
    *************************************************************************************
    Hi Melissa,
    We would certainly be interested in receiving comments from patients unable to attend in person! For that purpose we have two services available for remote participation:
    1. Live webcast: You can register as a web participant on Eventbrite (http://www.eventbrite.com/e/functional-gi-disorders-patient…) to participate in the interactive webcast for the meeting. As a web participant, you will receive a link from this inbox a few days before the meeting with instructions on how to log in on the day of the meeting. Once the meeting begins and web participants are logged in, they will be able to view the meeting and presentation slides via a live video feed. They will also be prompted to answer polling questions, submit text comments, and respond to discussion questions throughout the meeting simultaneously with in-person attendees.
    2. Online public docket: This docket will be open from now until 2 months after the meeting takes place. Here, patients and other stakeholders can submit any comments related to the meeting, and we would be particularly interested in patient responses to the discussion questions posted. You can submit to the docket here:
    https://www.federalregister.gov/…/patient-focused-drug-deve….
    All input provided by patients and representatives via the above methods will be considered by FDA along with the comments provided by in-person participants. Comments will then be summarized into our final “Voice of the Patent” summary report and posted on our meeting website (http://www.fda.gov/…/…/PrescriptionDrugUserFee/ucm430885.htm) along with a full recording of the webcast and a transcript of the meeting.
    You can find materials and recordings of past PFDD meetings here to better understand the meeting format:
    http://www.fda.gov/…/…/PrescriptionDrugUserFee/ucm347317.htm
    I hope that answers your question, feel free to email me with any further concerns!

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