Regulatory Open Forum

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  • 1.  Label Update

    Posted 27-Jun-2019 08:55
    It's been a bit since I worked on a label update, but what I know for sure is that if there are changes to the PI, and ISI it impacts all of your materials that were reported to the FDA.  What other materials could be impacted?

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    Love Hubbard
    Regulatory Manager, MLR
    Trevose PA
    United States
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  • 2.  RE: Label Update

    Posted 11-Jul-2019 09:23
    Hi Love,

    When a PI is updated and the new sections affect the ISI, I would update the ISI on all marketing materials that are currently in use (especially if they'll be in use for a while) and resubmit those changes to OPDP (with updated PI, of course). I'd also ensure that the marketing materials themselves don't contradict the changes to the label. For planning purposes, it might also be a good idea to ask your labeling team (or whoever is responsible for updates) if they expect any additional changes in the near future due to aligning with FDA guidance (eg, Pregnancy and Lactation Labeling Rule changes).  

    Hope that helps!
    Courtney

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    Courtney Portik
    Atlanta GA
    United States
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    Original Message


  • 3.  RE: Label Update

    Posted 11-Jul-2019 11:32
    Courtney Portik

    Thank you very much for replying to my post.  Yes, I agree.  Since my last post I spoke with some of my former label update colleagues and they mentioned that although the materials that were reported would be impacted it would also impact the language of materials that were not reported.  The Label update should be evaluated against all of your materials for the brand.

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    Love Hubbard
    Regulatory Manager, MLR
    Trevose PA
    United States
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    Original Message


  • 4.  RE: Label Update

    Posted 12-Jul-2019 11:03

    If your Medical Affairs department or Call Center uses standard query responses it could impact some of those.  If you have any ongoing clinical trials with the product, it could impact the Investigator's Brochure.



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    Robyn Walsh
    Regulatory Affairs, Sr. Manager
    Danbury CT
    United States
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    Original Message


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