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A Target Product Profile Framework to Guide Patient-Centered Development, Regulatory Approval, and Market Access of Digital Therapeutics for Substance Use Disorders
Background: Digital therapeutics (DTx) offer a scalable means of addressing persistent barriers to substance use disorder (SUD) care, including stigma, provider shortages, and geographic inaccessibility. SUD was the first therapeutic area in which the U.S. Food and Drug Administration (FDA
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