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irth in Medicaid. Changes in Medicaid and other public policy to reduce disincentives for pregnant and parenting women to report substance use during medical visits and to increase providers' abilities and motivation to equitably screen for as well as treat women with SUDs before, during, and after pregnancy could improve outcomes for mothers and their children. Improvements in SUD diagnosis would also improve prevalence estimates of specific types of SUD, which could contribute to better Medicaid policies aimed at prevention and treatme

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Addressing these numerous challenges requires application of various risk mitigation strategies and meeting regulatory expectations specifically adapted to the product types. Regulatory cooperation and harmonisation at an international level are essential for progress in the development and commercialisation of these products. However, particularly in the area of cell therapy, new regulatory paradigms may be needed to harness the benefits of clinical progress in situations where the resources and motivation to pursue a typical drug product app