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US FDA Mulls ‘Orange Book’ Listing For Device, REMS, Digital App Patents

 
• By Sue Sutter

With an eye toward addressing uncertainty as to whether patents that cover drug products’ device components or risk management elements should be listed, the agency seeks input on the need for additional clarity around the types of patents that must be submitted and the impact of any change in listing practices on drug development.

Patent files and documents in cabinet in office. 3D rendered illustration.
US FDA is re-evaluating the types of patents listed in the 'Orange Book.' • Source: Shutterstock

The US Food and Drug Administration is weighing the need for additional clarity about the types of patents that should be listed in the “Orange Book,” particularly those covering device components of combination products, risk management programs and digital therapeutics.

In a notice scheduled to appear in the Federal Register on 1 June, the agency seeks public comment on the types of patents currently listed in the Orange...

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