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Sharan Murugan
- Jan 23
- 2 min
USFDA's ISTAND Pilot Program: Accepts First Submission of AI-Based Digital Tech for Neuroscience
A new submission has been accepted into the FDA's Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program by...
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Sharan Murugan
- Jan 20
- 1 min
WHO Guidance: Ethics and Governance of Artificial Intelligence for Health
The World Health Organization (WHO) released new guidelines (18 January 2023) on ethics and governance of large multi-modal models...
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Sharan Murugan
- Oct 25, 2023
- 1 min
UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device
Earlier today (25 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated Guidance on "Software...
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Sharan Murugan
- Mar 30, 2023
- 1 min
USFDA Med Dev: Marketing Submission Recommendations for Change Control Plan for AI/ML Enabled Device
Earlier today (30 March 2023) USFDA released draft guidance on "Marketing Submission Recommendations for a Predetermined Change Control...
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Sharan Murugan
- Sep 21, 2022
- 3 min
Artificial Intelligence in Regulatory Affairs
Artificial Intelligence (AI) is a broad term that encompasses many different things and is a kind of intelligence that is created by a...
3,890 views0 comments