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#AI制药

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Oct 15Thu
  1. gov.uk51

    MHRA 2030 Strategy to modernise patient-centred regulation for the era of AI and personalised medicines

    The Medicines and Healthcare products Regulatory Agency (MHRA) has set out plans to modernise patient-centred regulation in preparation for an era of AI and personalised medicines. The strategy, running to 2030, aims to translate scientific and technological innovation into better health outcomes for patients across all four nations of the UK. Implementation of the strategy's measures is the next step for the agency.

    Why it matters: MHRA's 2030 strategy will shape how AI and personalised medicines are regulated in the UK.

Oct 6Tue
  1. statnews.com49

    STAT+: Utah plows ahead with more health AI pilots for prescriptions, women’s health

    Utah regulators announced a plan to let Nolla Health, a startup backed by $4.5 million from investors including General Catalyst, launch an AI service that assesses patients for mild-to-moderate acne treatment through structured intake and skin photo analysis. The AI may determine whether a low-risk drug from a list is appropriate; a licensed clinician will initially review and sign off on prescriptions, though Nolla may eventually prescribe without human review. The pilot expands Utah's AI sandbox program, in which the Office of Artificial Intelligence Policy can waive regulations for supervised testing of AI products.

    Why it matters: A state regulator is letting an AI product write prescriptions without prior human review, a first for US drug prescribing.

Oct 1Thu
  1. biospace.com47

    US government launches AI-driven programs to overhaul clinical trials

    ARPA-H has launched SURPASS, a program to speed up clinical trials of drugs and biologics through computational models, real-time analysis and automation, aiming to evaluate them faster, at lower cost and with fewer participants. It focuses on a phaseless design engine using digital twins, a continuous inference engine to cut control group size, and an agentic operations layer automating trial startup. ARPA-H also announced STACK, COMMONS and CINCH, covering site activation, national consent and patient data contribution, as the U.S. seeks to regain clinical trial leadership lost to China six years ago.

  2. statnews.com45

    STAT+: HHS announces new efforts to speed up, expand clinical trials with AI

    HHS announced initiatives to speed up clinical trials by using more artificial intelligence and computational models and moving away from sharply delineated trial phases. The centerpiece is SURPASS, a five-year program for "Simulation-augmented, Real-time Platform Adaptive Seamless Trials" run through the Advanced Research Projects Agency for Health, which will start accepting ideas from cross-disciplinary teams this fall. The announcement did not specify funding or additional flexibility for participants.

Sep 11Fri
Sep 10Thu
  1. statnews.com40

    STAT+: U.K. unveils recommendations for regulating AI in medicine

    A U.K. commission issued 44 recommendations for regulating artificial intelligence in medicine, aiming to balance AI's potential, such as reviewing millions of diabetes eye scans each year, with safety and equitable treatment. The proposals include staged authorization of new AI models and a system for providers to report how tools perform in clinics, including malfunctions, as models adapt over time.

    Why it matters: Sets a regulatory direction for AI medical tools that parallels deliberations by authorities in the U.S. and elsewhere.

Aug 24Mon
  1. statnews.com57

    STAT+: FDA digital health leader promises generative AI regulatory guidance is coming

    The FDA is developing a plan to regulate medical devices that use generative artificial intelligence and will eventually release documents spelling out its policies, Rick Abramson, director of the agency's Digital Health Center of Excellence, told STAT. Abramson said the goal is formal policy guidance, including broad guidance on generative AI plus narrower specialty guidance on topics of special interest or complexity. The agency is also considering a competency-based approach.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org