Regulatory Open Forum

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  • 1.  Regenerative Medicine FDA Regulations - Overview

    Posted 07-Jan-2021 12:46
    Hi all,

    Was wondering if anyone has a good resource summary of regenerative medicine FDA regulations and how they differ from standard biologics.  Looking at all lifecycle of the product.  Any other regulatory information on regenerative medicine will be welcomed.
    Resource can be a comparison table, an article, or PowerPoint presentation.

    Thank you

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    Malka Fraiman
    Davie FL
    United States
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  • 2.  RE: Regenerative Medicine FDA Regulations - Overview

    Posted 19-Jan-2021 16:46
    Edited by Lance Tovar 19-Jan-2021 16:48
    Hi,

    Check out 21 CFR 1271.  A little more explanation on what your product is, would help others give better guidance on the matter.

    Hope this helps

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    Lance Tovar
    RA/QA Specialist
    Roy UT
    United States
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    Original Message


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