Drug-Device Combos Divide Orange Book Feedback

Law360 (September 4, 2020, 5:39 PM EDT) -- Major drugmakers, attorneys general and pharma trade organizations have given the U.S. Food and Drug Administration conflicting arguments on whether patents for drug-device combinations and established risk evaluation and mitigation strategies should be added to the Orange Book.

The agency had asked for a variety of critiques about the generic-drug guide, which is turning 40 years old in October, and comments rolled in by the Aug. 31 deadline. When it comes to expanding what patents should be included, drug-device combinations are a particularly divisive area.

The idea of what to list is controversial because when a generic-drug company files an abbreviated...

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