Regulatory Open Forum

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  • 1.  Advisory Committee Research

    Posted 08-Nov-2015 08:38

    Dear Sir or Madam,

    I represent a group of students from the University of Maryland University College (UMUC) Masters in Biotechnology Regulatory Affairs program. We are in our capstone project working with a sponsor, ECG (www.ecglink.com), a strategic communications consulting company. We have created a survey with a goal of determining factors that contribute to the success or failure of an advisory committee meeting as well as the member's opinions on the meeting materials made available to them by the sponsors. We have sent this survey to FDA advisory committee members, but would also like to utilize the RAPS community to gain further insight from a different perspective. Please be aware that many of these questions will be directed as if you were  advisory committee members, but we would like your perspective. Responses can be left blank if you wish to skip questions. The survey has been modified slightly to capture the fact that it is RAPS members responding. Our project will not list any personal information that could identify you to the responses provided. We appreciate your input and look forward to your response. Please feel free to respond to me directly with any questions, comments, or concerns.

    Link to the survey: http://goo.gl/forms/AFBQD9t5XH

    Thank you for your time,

    Classmates:

    Sunil Baniya

    Hawa Camara

    Marleen Cook

    Abigail Monaco

    Sherrie Pettiford

    Brianna Push

    Melissa Rayner

    Benjamin Rush

     

    ------------------------------
    [Abby] [Monaco] [MLS(ASCP)CM]
    Graduate Student
    University of Maryland University College
    ------------------------------


  • 2.  RE: Advisory Committee Research

    Posted 08-Nov-2015 14:47
    Abigail,

    Good to see your initiatives!

    In fact, almost for the past ten years, I've attended over eighty (80) FDA advisory meetings (either in person or online - both combined) and reviewed FDA materials and analyzed FDA decision making processes.

    I even proposed to the FDA what/how to develop a systemic communication system (was mainly based on my analysis after reviewing FDA-generated materials and attending a lot of FDA advisory meetings as I briefly described at <http://regulatorydoctor.us/david-lim-proposal-in-2008-to-fda-and-fdas-release-of-the-report-for-building-an-effective-nmdss/>

    To make my points simple, your proposed "survey with a goal of determining factors that contribute to the success or failure of an advisory committee meeting..." may be fundamentally flawed for the following reasons.

    1). There is no definition clearly defined of what constitutes "success or failure" of the advisory committee meeting.  
    2). Even if it is defined, the success or failure can be somewhat triggered by few or more than few factors including, but not limited to, diplomatic, political, and/or social reasons, etc.

    I would recommend/suggest you or your team re-rationalize the survey questions for the following goal.

    "determining what factors are considered to be critical to best present your case before the FDA advisory committee meeting."

    Among many criteria, you may add like whether having a "drama effect" can influence the decision during the public presentation session; for example here. 

    Disclaimer: the term "drama effect" doesn't constitute or shouldn't be interpreted to constitute my intent, either explicitly or implicitly, to undermine patients' pain or suffering or experience in any drug, device or other medical products in any way, shape, form or manner.  This is for informational purposes only.  

    Even regardless of an FDA meeting and FDA decision based on the FDA advisory committee meeting, this dramatic movement may/can happen as a recent case here >>

    Are big companies ready for this potential legislative movement? 

    Thank you.  

    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
    Phone (Toll-Free): 1-(800) 321-8567


    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

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