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FDA Guidance on Regen Med

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    FDA releases final regenerative medicine guidances

    FDA Friday released final versions of two guidance documents that are intended to facilitate the development of regenerative medicines.

    Draft versions of the Evaluation of Devices Used with Regenerative Medicine Advanced Therapies and Expedited Programs for Regenerative Medicine Therapies for Serious Conditions were released in November 2017.

    In the final guidance on expedited pathways, FDA confirmed that sponsors can apply for and receive both breakthrough and regenerative medicine advanced therapy (RMAT) designation for a product.

    RMAT provides all of the benefits of breakthrough, including early and intensified interactions with senior FDA officials. The threshold for receiving RMAT designation is lower than for breakthrough.

    RMAT is available to cell therapies and tissue products for which there is preliminary evidence of a potential to address an unmet medical need for a serious or life-threatening condition.

    Breakthrough designation is contingent on demonstration of the potential to provide a substantial improvement over available therapies.

    FDA also reiterated its decision to include gene therapies in the RMAT pathway. This decision stretched the definition that was in the 21st Century Cures Act, which created RMAT.

    FDA has gone a step further in broadening RMAT by defining CAR T therapies as gene therapies, making them eligible for RMAT.

    In the final guidance, the agency tweaked the definition of qualifying gene therapies, substituting the requirement that they produce a “sustained” effect on cells or tissues for the previous requirement that gene therapies produce a “durable modification.”

    “The speed in which FDA is putting out draft guidances on regenerative medicines and turning them around is remarkable and is indicative of how much they believe in this technology,” Michael Werner, co-founder and senior policy counsel to the Alliance for Regenerative Medicine, told BioCentury. Back to top


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