Regulatory Open Forum

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  • 1.  Diversity Plans

    Posted 25-Mar-2024 11:20

    Just wondering if anyone has experience with FDA feedback on a diversity plan. Did FDA provide feedback and was it useful? For now these plans seem to be "recommended". Does anyone have experience of being asked for one when it wasn't voluntarily provided?



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    William Sietsema
    Vice President, Global Regulatory Affairs
    Lisata Therapeutics, Inc.
    Rancho Santa Margarita CA
    United States
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  • 2.  RE: Diversity Plans

    Posted 26-Mar-2024 08:39

    You may want to review this FDA website on diversity and look at the stats for the "Year One Experience": https://www.fda.gov/about-fda/oncology-center-excellence/project-equity



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    Michael Bui
    Senior Vice President, Regulatory Affairs
    Pyxis Oncology
    Arlington MA
    United States
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    Original Message


  • 3.  RE: Diversity Plans

    Posted 27-Mar-2024 09:25

    Michael, That link was a good resource of first-year experiences with diversity plans.  It looks like, at least for Oncology related applications, most of the feedback was on enrollment goals, enrollment monitoring, and enhancing strategies to meet goals.  I assume that observation infers we need to have more than expectations of diverse representation and include proactive plans for achieving those goals and dealing with contingencies.  Thanks for posting the link.  --Andy Hadd



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    Andrew Hadd
    Director of Regulatory Affairs
    Natera
    Austin TX
    United States
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    Original Message


  • 4.  RE: Diversity Plans

    Posted 27-Mar-2024 14:37

    Hi Michael, 

    Thank you for sharing. What an excellent resource this was to provide insight into what we should anticipate.



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    Sheila Hittesdorf
    Vaxcyte Inc
    Hightstown NJ
    United States
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    Original Message


  • 5.  RE: Diversity Plans

    Posted 26-Mar-2024 09:44

    The FDA requested it shortly after our submission. We recently submitted a Diversity Plan and are awaiting feedback. The guidance doesn't indicate how many days for review, but I'm guessing 60 days.



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    Sheila Hittesdorf
    Vaxcyte Inc
    Hightstown NJ
    United States
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    Original Message


  • 6.  RE: Diversity Plans

    Posted 27-Mar-2024 09:27

    We submitted a Diversity Plan to our IND during Phase 3 and received a response from FDA in 5 months.

     "...plan appears generally reasonable at this time...The Division continues to develop its approach to the review of diversity plans...and we may provide further feedback as your development plan progresses. As your development program progresses and you receive community input, you should provide more detailed specification of the trial enrollment and retention strategies (e.g., modifications for persons with disabilities, reduce frequency of trial-related procedures) and include the specific actions to be implemented during the conduct of the trial if planned enrollment goals are not met. In addition, you may consider addressing other non-demographic factors (e.g., socioeconomic status) in your plan.



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    Tom Stothoff
    Senior Director, Regulatory Affairs CMC
    Chicago
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    Original Message


  • 7.  RE: Diversity Plans

    Posted 27-Mar-2024 17:22

    Great feedback from everyone, this is very helpful!



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    William Sietsema
    Vice President, Global Regulatory Affairs
    Lisata Therapeutics, Inc.
    Rancho Santa Margarita CA
    United States
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    Original Message


  • 8.  RE: Diversity Plans

    This message was posted by a user wishing to remain anonymous
    Posted 26-Mar-2024 16:40
    This message was posted by a user wishing to remain anonymous

    We included one in our IDE and received no questions on it. No experience on FDA feedback and it seemed like the right thing to do for future users.


    Original Message


  • 9.  RE: Diversity Plans

    This message was posted by a user wishing to remain anonymous
    Posted 27-Mar-2024 16:58
    This message was posted by a user wishing to remain anonymous

    We submitted a proposed diversity plan (drafted following the guidance) for FDA feedback in a pre-sub, since we anticipate the diversity plan being a requirement by the time we submit for 510(k).

    The feedback we got was moderately useful: "Your efforts to ensure racial and ethnic diversity in the clinical study for your device seem to be appropriate. Please note that the requirement to submit Diversity Action Plans applies to future clinical studies for which enrollment will commence 180 days after publication of final guidance on Diversity Action Plans."


    Original Message


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