FDA Proposes Legislation To Create A Safe Harbor For Skinny Labeling

By Beth Wang / March 9, 2023 at 7:25 PM
FDA wants Congress to create a safe harbor that protects generic drug makers from being held liable for patent infringement when they market a drug with a so-called skinny label -- that is, when a generic drug manufacturer’s product is approved and marketed for one or more off-patent uses of a brand drug, and only the off-patent uses are reflected in the drug’s label. The administration is proposing the legislation due to a federal appeals court decision last year that...

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