FDA Pushes Legislative Proposals To Boost Generic Competition

By Jessica Karins / March 13, 2024 at 3:51 PM
FDA’s slate of legislative proposals for fiscal 2025 includes calls for Congress to encourage generic drug competition, such as by eliminating distinctions between biosimilar and interchangeable drugs, amending exclusivity provisions and creating a safe harbor for “skinny labeling.” The agency’s document laying out its legislative proposals includes a section on facilitating competition, which also requests Congress require full ingredient disclosure for drugs, close patent litigation loopholes, ease requirements for generic drug-device combination products and enhance the availability of generic animal...


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