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United States - Life Sciences, Biotechnology & Nanotechnology - FDA Provides Updates To Congress On FDORA, User Fee Implementation

FDA provided an update on the implementation of new accelerated approval authorities and emphasized that drugs approved under the pathway meet efficacy requirements. ....

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The Regulatory Race Is On: The Biden Administration Sprints To Issue Key Health Policies - Healthcare

The upcoming election, and the approaching end of the President's four-year term, introduce additional dynamics into the agencies' rulemaking process and even the guidance process. ....

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Virtual And Digital Health Digest - Healthcare

Welcome to the next installment of Arnold & Porter's Virtual and Digital Health Digest. This edition primarily covers March 2023 highlights across the virtual and digital health space. ....

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FDA's Holiday Present From Congress: Bipartisan Reforms To The Accelerated Approval Framework, Long-Awaited Cosmetic Modernization, And Expansion Of Certain Existing Programs - Healthcare

On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act for 2023, colloquially referred to as the omnibus funding bill, that includes a similarly expansive. ....

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