AI

Report Shows Extent Of AI Use In EU Medicines Regulation During 2024

 

The AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.

Beijing City Releases AI Action Plan Including Drug Regulation

 
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Amid the wait for an action plan to apply AI tools to drug regulation at the national level in China, capital city Beijing has released its own vision of scenarios for the technology in the healthcare sector.

ANDA User Fees: Complex Generics, Transparency, Communications Are Early Negotiation Targets

 
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Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.

Kris Joshi Named Norstella CEO, Prioritizes AI Innovation

 
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Joshi joins the parent company of Citeline, home of the Pink Sheet, to focus on AI, business harmonization and long-term growth.


AI And Inertia: The Disruptors Keeping EU Regulators Awake At Night

 

Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.

AI In Manufacturing: EU To Revamp GMP Guidance In Light Of Digital Advancements

 

Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.

US FDA’s Elsa AI Platform Is Not Guiding Regulatory Decisions, Official Says

 
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Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
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Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.


Profit-Sharing AI Model Proposed To Boost Korean Drug R&D

 
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A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges

Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.

Scientists Work With AI To Uncover ‘Unexpected’ Drug Combos For Breast Cancer

 

A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.

US HHS Deputy Nominee Talks AI, Not FDA, In Confirmation Hearing

 

Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.


Canada’s HTA Agency Reveals How To Submit AI-Driven Evidence

 

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.

AI Could Be Used ‘In The Deliberation’ Of HTA Reviews In England, Says NICE

 

England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.

EMA’s Newly Qualified AI Tool To Boost MASH Market Dynamics

 

The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.

US FDA Under Makary: MAHA With A Lighter Touch

 

US FDA Commissioner nominee Martin Makary is being embraced by industry, and Senate Democrats, as a more traditional pick than other Trump Administration nominees, but the Make America Healthy Again agenda still is clearly coming to the agency.


Weekend US FDA Layoffs Cost Device Center Many AI And Digital Health Staffers

 

The exact number of layoffs at the FDA as part of the Trump Administration’s pledge to shrink the federal government is unclear, but the most came from the agency’s Center for Devices and Radiological Health.

EU AI Act: Pharma Companies Advised To Act Now To Ensure AI Literacy Under New Rules

 

Pharmaceutical companies in the EU have until August to ensure their staff have an adequate level of artificial intelligence literacy in line with new obligations set by the AI Act this month.

Digital Health Head, AI Leader Tazbaz Leaves US FDA

 
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The former Oracle executive spent two years in the post, following founding director Bakul Patel, and is another high-level resignation from the agency as the Trump transition continues.

Artificial Intelligence: US FDA Outlines 7 Steps To Establishing Model Credibility

 
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The risk-based framework described in a new draft guidance starts with defining the question of interest and context of use and includes development and execution of a credibility assessment plan. The guidance is limited to AI models used to support regulatory decisions about drug safety, effectiveness or quality.