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USFDA Draft Guidance: Considerations for the Use of Artificial Intelligence to Support Regulatory Decision
The U.S. Food and Drug Administration (FDA) released a draft guidance earlier today (07 January, 2025) outlining " Considerations for...
Sharan Murugan
Jan 72 min read
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UK MHRA Press Release Trials Innovative AI Technologies in Regulatory Pilot Scheme
The UK Medicines and Healthcare Products Regulatory Agency (MHRA)Â has launched (4th December 2024) a groundbreaking pilot scheme "...
Sharan Murugan
Dec 4, 20242 min read
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EMA: Harnessing AI in Medicines Regulation: The Role of Large Language Models (LLMs)
The advancement of Artificial Intelligence (AI) Â is transforming many industries, and the pharmaceutical and regulatory sectors are no...
Sharan Murugan
Sep 15, 20242 min read
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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...
Sharan Murugan
Sep 21, 20223 min read
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Free eBook- CAPA in the Pharmaceutical and Biotech Industries
According to the U.S. Food and Drug Administration (FDA), the purpose of a "CAPA program is to collect information, analyze information,...
Sharan Murugan
May 26, 20221 min read
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