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US FDA Weighs Patent Listing Requirements For Digital Apps Used With Drugs

 
• By Sue Sutter

Agency is considering whether patents for digital apps used in conjunction with approved drugs should be listed in the 'Orange Book’; modernization plan for the compendium includes new guidance on therapeutic equivalence ratings to help clarify path for fully substitutable 505(b)(2) NDA products.

Black Office Folder with Inscription Patents on Office Desktop with Office Supplies and Modern Laptop. Patents Business Concept on Blurred Background. Patents - Toned Image. 3D. - Illustration

The US FDA is weighing whether patents covering digital applications used with approved drugs should be listed in the “Orange Book” as part of the agency’s efforts to modernize the compendium.

In a Jan. 30 announcement about new guidance and other initiatives aimed at making the Orange Book a more useful...

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