All Artificial intelligence (AI) articles
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Industry newsFDA releases new draft guidance on assessing artificial intelligence data
The US Food and Drug Administration (FDA) has released new draft guidance which provides a risk-based credibility framework that can be used for assessing artificial intelligence (AI) data in the drug product lifecycle.
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JournalThe role of artificial intelligence in regulatory affairs
This article explores the enormous potential of artificial intelligence (AI) technologies in regulatory affairs, highlighting how AI can streamline regulatory compliance, expedite submissions, enhance predictive analytics for decision-making, improve pharmacovigilance and elevate regulatory intelligence when properly applied. The discussion covers not only the advantages of AI but also the complexities of integrating AI into regulatory affairs, such as the challenges of algorithm interpretability, data quality, regulatory compliance, fairness, security, privacy and model accuracy. Additionally, it emphasises the collaborative efforts of the global regulatory community in developing guidelines and frameworks for the safe and effective use of AI.
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Industry newsRegulators publish new guidelines for use of AI
The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) publish new guiding principles for the use of large language models (LLMs) in regulatory affairs.
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Industry newsAI used to predict candidate antibiotics in radical study
AI machine learning algorithms have been used in a study to identify candidate compounds for investigation as potential new antibiotics.
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PodcastsRegRapPod − April 2024
Vol.21 #4: In April 2024’s RegRapPod, host Alan Booth talks to Issue Editor James McCormick about all things data.
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PodcastsRegRapPod − February 2024
Vol.21 #2: In February 2024’s RegRapPod, host Alan Booth talks to Issue Editors Dejan Brkic and Esteban Herrero-Martinez about medtech.
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CommentaryDeveloping a digital people strategy to harness the power of generative AI
Artificial intelligence is a science and applied technology that involves deductive processing and machine learning subsequently performing human-like tasks
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JournalAI meets medtech:
big opportunities
require a
measured approachRegulatory Rapporteur February 2024 | Volume 21 | No.2 Abstract Artificial intelligence (AI) and machine learning (ML)-enabled digital health technologies have great potential to improve patient care, strengthen diagnostic capabilities and enhance treatment options. Governments and healthcare professionals understand ...
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Industry newsDevice which can detect skin cancer approved by FDA
The FDA has approved a wireless hand-held device that uses an artificial intelligence-powered algorithm to detect skin cancer.
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Podcasts
RegRapPod − January 2024
Vol.21 #1: In January 2024’s RegRapPod, host Alan Booth talks to Issue Editors Julie Warner and Ash Ramzan about biologics.
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JournalArtificial intelligence in drug discovery
Regulatory Rapporteur January 2024 | Volume 21 | No.1 Introduction The recent publication of papers by the European Medicines Agency (EMA)[1] and the Food and Drug Administration (FDA)[2][3] has spurred the debate on ...
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Industry newsEMA/HMA publish workplan for the responsible use of AI
The EMA and the HMA have published a multi-annual AI workplan 2023-2028 to facilitate the safe and effective use of artificial intelligence.
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VideoICMRA regulators to mark its 10th year at event in Australia
International Coalition of Medicines Regulatory Authorities set to celebrate 10 years of strategic leadership at Melbourne summit.
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Industry newsFDA to establish Digital Health Advisory Committee
The FDA has established a Digital Health Advisory Committee to help the agency explore issues related to digital health technologies (DHTs).