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On September 19, 2023, the U.S. Food and Drug Administration ("FDA" or "the Agency") published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the "Guidance").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

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On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software.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

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