Regulatory Open Forum

 View Only

  • 1.  Rx to OTC Switch Studies

    Posted 14-Jan-2014 09:22
    How long, on average, does it take to conduct Rx to OTC behavioral (Label comprehension, self-section, and actual use) studies? From design to completion?

    Thanks!
    Rosey

    -------------------------------------------
    Rosemary Teresi
    Associate Scientific Director
    ProEd Communications
    Beachwood OH
    United States
    -------------------------------------------


  • 2.  RE:Rx to OTC Switch Studies

    Posted 15-Jan-2014 09:34

    Hi Rosey,

    Someone will hopefully answer your question but there is a webinar today being offered by CHPA specifically talking about switching Rx to OTC. 

    http://webinars.chpa.org/session.php?id=12332

    -------------------------------------------
    Alison Trado
    Coordinator, Regulatory and Quality Affairs
    Wellspring Pharmaceutical Corporation
    Sarasota FL
    United States
    -------------------------------------------






    Original Message


  • 3.  RE:Rx to OTC Switch Studies

    Posted 08-Mar-2014 02:35
    Dear Rosey,

    It takes about 4-6 months to finalize the protocol and the questanaire and get it approved by the FDA.
    I would like to share and ask you questions regarding the actual implementation of the study itself.

    Please email.

    -------------------------------------------
    Yoram Levy
    General Manager
    QSite
    Binyamina
    Israel
    -------------------------------------------






    Original Message


  • 4.  RE:Rx to OTC Switch Studies

    Posted 10-Mar-2014 08:44
    We at PEGUS Research have been conducting the full range of OTC switch studies for over 20 years and would be happy to answer questions more specifically than might be possible on this site. I can be reached at dave@pegus.com.

    David Bradford, Senior VP for OTC Switches, PEGUS Research

    -------------------------------------------
    Marcia Howard
    Senior Director, Regulatory & Scientific Affairs
    Consumer Healthcare Products Association
    Washington DC
    United States
    -------------------------------------------






    Original Message