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Success will require sustained commitment from multiple stakeholders over many years (Zondervan et al., 2020)

doi: 10.1016/j.neuro 65 MashibaSWadaYTakeyaMSugiyamaAHamakuboTNakamuraAet al

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This regulatory pathway enables the applicant to rely, in part, on the FDAs prior findings of safety and efficacy for an existing product, or published literature, in support of its application