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The U.S. Food and Drug Administration (FDA) has introduced a new pilot program to prioritize Abbreviated New Drug Applications (ANDAs)...
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The U.S. Food and Drug Administration (FDA) is offering an opportunity for stakeholders to provide feedback to “advance a broader...
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Texas is imposing new rules for the storage of electronic health records (“EHR”). Recently enacted Senate Bill 1188 (“SB 1188”) requires...
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On September 9, 2025, the U.S. Food and Drug Administration (FDA) announced it is launching a targeted initiative to combat deceptive...
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On September 5, 2025, the U.S. Food and Drug Administration (FDA) announced the establishment of a "green list" import alert (Import...
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As a follow-up to its recent announcement of the new Wasteful and Inappropriate Service Reduction (WISeR) Model (which we have previously...
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Often there is a lot of attention paid to the Centers for Medicare & Medicaid Services (“CMS”) Inpatient Prospective Payment System...
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On August 7, 2025, the Food and Drug Administration announced a voluntary “FDA Pre-Check” program to encourage and expedite domestic drug...
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On July 15, the U.S. Secretary of Agriculture, Brooke L. Rollins, announced a “comprehensive plan to bolster U.S. Department of...
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On July 9, 2025, the Federal Trade Commission (“FTC”) hosted a workshop to discuss unfair and/or deceptive trade practices in gender...
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In a significant move toward greater labeling transparency and state oversight of food policy, Texas and Louisiana have enacted new laws...
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On June 30, the Joint Commission announced it is transforming its accreditation process, promising a more streamlined, relevant, and...
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CMS recently announced a new model it will be using to pilot the use of artificial intelligence and machine learning in reviewing prior...
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On June 18, 2025, the U.S. Food and Drug Administration (“FDA”) announced an immediate review of new clinical trials that export American...
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On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the...
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In 2024, the U.S. Department of Health and Human Services’ (“HHS”) implemented a new privacy rule under the Health Insurance Portability...