The Same But Different: Biden Budget Proposes Flexibility For Generic Drug-Device Combos, ‘Skinny Labels’
President Biden's fiscal year 2024 budget pushes new legislative changes to get generic drugs to market faster.
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US Lawmakers Seek Next-Pandemic Advice For Renewing Preparedness Law
House bipartisan legislators seek input as the appropriate mix of incentives for next-generation public-private ventures remains elusive.
Generic Policy Tweaks In Omnibus Legislation Include Processes Improvements On Late-Stage Label Changes, 505(b)(2) TE Designations
FDA will be able to approve some interchangeable biosimilars more smoothly, but won’t be instructed to provide ANDA sponsors with more information on the inactive ingredients in brand drugs.
US Supreme Court Preview: ‘Skinny’ Labels, FTC, And FCA – But No Tecfidera As Biogen Loses Bid
Teva’s carve-out fight with GSK over generic Coreg will see the Solicitor General weigh in. Amgen and Juno’s patent petitions remain pending, and the high court stays a Federal Circuit decision invalidating Novartis’ Gilenya patent.