#方法/工具

#方法/工具

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Oct 6Tue

Tuesday

04:15
fda.govPickScore6464
M15 Resource Center
The FDA has posted a resource center for ICH M15, a guidance on general principles for model-informed drug development (MIDD). The guidance describes MIDD principles, including planning, model evaluation and evidence documentation, sets a harmonized framework for assessing MIDD-derived evidence, and gives recommendations on MIDD-related regulatory interactions, reporting and submission. FDA recommends sponsors use it when preparing meeting requests, background packages and regulatory submissions.
Regulatory #Regulatory #Methods & tools #FDA
Why it matters: FDA now expects ICH M15 principles to shape MIDD evidence in submissions and meetings.

Oct 1Thu

Thursday

23:05
biospace.comScore4747
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.
Regulatory #Policy & payers #Methods & tools #AI in drug discovery

Sep 10Thu

Thursday

11:01
statnews.comPickScore4040
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.
Regulatory #Policy & payers #AI in drug discovery #Methods & tools
Why it matters: Sets a regulatory direction for AI medical tools that parallels deliberations by authorities in the U.S. and elsewhere.