2025 fourth_quarter Filing

Federal policy relating to providing incentives and federal funding to strengthen capabilities for domestic manufacturing of generic drugs; and Federal policy relating to amending the Hatch-Waxman Act to provide incentives for manufacturing generic pharmaceuticals and their ingredients in the United States and allied nations.

Federal policy relating to addressing drug shortages and strengthening pharmaceutical supply chains through partnerships with North American and other allied countries; Federal policy relating to providing preferential federal direct and indirect purchasing treatment for domestic and North American manufactured pharmaceuticals; S. 43, Skinny Labels Big Savings Act, provisions relating to providing a safe harbor from infringement for a method of use patent relating to drugs or biological products; and HR 1483/S. 1302, The Increasing Transparency in Generic Drug Applications Act, provisions relating to the Food and Drug Administrations authority to share information about ingredients and deviations in inactive ingredient concentration with generic pharmaceutical product applicants.