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Robert Sowell, former Assistant US Attorney for the Middle District of Florida, rejoins BakerHostetler’s Commercial Litigation team in Orlando

Regulatory Horizons

Regulatory Horizons: What Life Sciences Companies Should Know About the BIOSECURE Act

Jacqueline Romero Comments on FCA Expansion Plan and Compliance Risk in Law360 Article

Children’s Privacy and App Store Accountability: The Risks of Knowing Too Much (CPI TechREG Chronicle)

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Today’s topic is a big one: the BIOSECURE Act, signed into law on December 18, 2025, as part of the FY 2026 National Defense Authorization Act. The law restricts federal agencies, contractors, and grant recipients from procuring or using biotechnology equipment or services from what the statute calls “biotechnology companies of concern.” This is more than a procurement rule—it has broad implications for biopharma, device companies, CDMOs, CROs, genomics companies, and even research institutions relying on federal funds. Implementation timelines, designations, and compliance obligations are already starting to take shape.

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Questions and Comments: <a href="mailto:wkirton@bakerlaw.com">wkirton@bakerlaw.com</a> and <a href="mailto:ahiggins@bakerlaw.com">ahiggins@bakerlaw.com</a>

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