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The U.S. Food and Drug Administration ("FDA") released a draft guidance document in January 2026 titled "FDA Records Access Authority for...
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On January 27, 2026, the Department of Health and Human Services, Office of Inspector General (“OIG”) published a Special Advisory...
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Congress Probes Chinese Biotech GLP-1 Product Compliance Although the FDA recently implemented additional safeguards related to imported...
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On January 6, 2026, the FDA issued a Guidance for Industry and Food and Drug Administration Staff regarding Clinical Decision Support...
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The January 2026 Cybersecurity Newsletter released by the U.S. Department of Health and Human Services Office for Civil Rights focuses on...
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On December 1, 2025, the Centers for Medicare & Medicaid Services (“CMS”) published its annual update to the Designated Health Services...
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Medical spas (commonly called “med spas”) blend the clinical capabilities of an aesthetic medical practice with the hospitality and...
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Medicare is launching a significant new prior authorization initiative under the CMS Innovation Center’s Wasteful and Inappropriate...
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On November 12, 2025, the New England Journal of Medicine published an article authored by FDA Commissioner Marty Makary and Center for...
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California has enacted two new laws—AB 1415 and SB 351—effective January 1, 2026, that will materially affect private equity ownership...
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On September 17, 2025, the Joint Commission, in collaboration with the Coalition for Health AI (“CHAI”), issued its first high-level...
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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...