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FDA Issues New Draft Guidance on Regulatory Considerations for Prescription Drug Use-Related Software | Arnall Golden Gregory LLP

New technologies continue to emerge that improve care for patients taking prescription medications. On September 18, 2023, five years after the Food and Drug Administration sought.

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Better Therapeutics (BTTX) Announces New Data Highlighting Concurrent Use of AspyreRx and GLP-1 Receptor Agonists to Treat Type 2 Diabetes

Better Therapeutics (BTTX) Announces New Data Highlighting Concurrent Use of AspyreRx and GLP-1 Receptor Agonists to Treat Type 2 Diabetes
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Better Therapeutics Announces New Data Highlighting Concurrent Use of AspyreRx and GLP-1 Receptor Agonists to Treat Type 2 Diabetes

Pivotal trial established use of AspyreRx alongside standard of care demonstrating clinically meaningful and statistically significant reduction in HbA1c leading to FDA authorization In a subgroup.

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Drug Use-Related Software Back in the Spotlight at the U S Food and Drug Administration | Wilson Sonsini Goodrich & Rosati

In late September 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software.” This guidance.

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On September 19, 2023, the U.S. Food and Drug Administration ("FDA" or "the Agency") published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the "Guidance").

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