The US Food and Drug Administration is applying the principles of the platform technology designation to situations that may not technically qualify for the program in order to speed the approval of multiple indications for cell and gene therapies.
Key Takeaways
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Sponsors may be able to take advantage of the platform technology designation concept without a qualifying product.
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Maintaining early product samples and manufacturing data may prevent comparability challenges that delay approvals
The platform technology pathway was created by the 2022 Food and Drug Omnibus Reform Act to streamline development of products that rely on a common backbone to treat different diseases. The designation has drawn particular attention in the gene therapy space where it is common to use the same vector for multiple indications. (Also see "Sen. Burr’s Parting Gifts For US FDA Include ‘Platform’ Pathway" - Pink Sheet, 5 January, 2023
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