The Priority Review

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prescription drug apps

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  1. Regulation

    FDA issues final guidance on prescription drug apps and software

    The FDA released final guidance on October 20, 2026 that clarifies when app content is subject to FDA submission requirements and when it should be mentioned on a drug's official label. The guidance identifies two categories of companion software-apps connected to a medical device and standalone apps-and sets conditions for labeling and what companies should submit to the agency.