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

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On September 19, 2023, the U.S. Food and Drug Administration ("FDA" or "the Agency") published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the "Guidance")...

Source: mondaq.com
FDA And Prescription Drug Use Related Software – FDA's Draft PDURS Guidance Answers Years-Old Questions And Introduces New Ones - Healthcare - Vimarsana News

FDA And Prescription Drug Use Related Software – FDA's Draft PDURS Guidance Answers Years-Old Questions And Introduces New Ones - Healthcare

After remaining silent on the topic for decades, the FDA provided an expansive definition of "promotional labeling" in its recently issued draft guidance document on Regulatory Considerations...

Source: mondaq.com