Regulatory Open Forum

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  • 1.  Diversity Plan Survey – Responses Requested by September 28th

    Posted 07-Sep-2023 13:55

    Your input is needed on a survey to learn about current progress toward FDA's draft guidance on Diversity Plans. Please take 2 minutes to complete the survey by September 28, 2023.

    Last year, FDA released a draft guidance recommending that sponsors submit Diversity Plans to improve representation in clinical trials. In Diversity Plans, sponsors set goals and develop strategies to increase participation of underrepresented racial and ethnic groups.

    We can all benefit from learning more about progress toward enhancing diversity in drug development, so please share your thoughts. We will share all results!

    Please access the survey HERE or at the QR code below:



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    Blake Schouest
    Scientific Medical Writer
    Aroga Biosciences
    San Diego CA
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  • 2.  RE: Diversity Plan Survey – Responses Requested by September 28th

    Posted 25-Mar-2024 11:18

    Great idea to do this survey. Will you be posting the results?



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    William Sietsema
    Vice President, Global Regulatory Affairs
    Caladrius Biosciences, Inc
    Rancho Santa Margarita CA
    United States
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  • 3.  RE: Diversity Plan Survey – Responses Requested by September 28th

    Posted 30 days ago

    Hi William,

    Our findings will be published in Therapeutic Innovation & Regulatory Science. I'll follow up when this is published. Please stay posted!

    Thanks,

    Blake



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    Blake Schouest
    San Marcos CA
    United States
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