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FDA Clarifies Labeling Expectations For Prescription Drug Use-Related Software - Healthcare

On September 19, 2023, the U.S. Food and Drug Administration ("FDA" or "the Agency") published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the "Guidance").

Drug administrationRadiological healthSoftware functionsSoftware the guidanceSoftware functionRegulatory considerationsPrescription drug use related softwareUser outputDrug use related softwareEnd user outputPrescription drug use relatedConnected prescription drug use related softwareConnected softwareTwo categoriesUser outputsEnd user outputs

FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software | Sheppard Mullin Richter & Hampton LLP

On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software.

Software functionRadiological healthSheppard mullin richter hamptonSoftware the guidanceSoftware functions deviceSoftware functionsDrug administrationSheppard mullin richterRegulatory considerationsPrescription drug use related softwareUser outputDrug use related softwareEnd user outputPrescription drug use relatedConnected softwareUser outputs

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