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Regulatory Intelligence Sources and Databases: A Complete Guide for Today’s Pharma, Biotech, and MedTech Teams
Staying compliant in the life sciences industry has never been more complex. Regulatory changes move faster than ever, global markets evolve continuously, and expectations from agencies keep rising. In this environment, regulatory intelligence is no longer a luxury. It is a core operational pillar. For my 1000th post on Regulatory Affairs News, I’m sharing a full breakdown of the latest regulatory intelligence sources, tools, databases, and best practices . I’m also attachin
Sharan Murugan
Nov 82 min read
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European Commission: Guidelines on the Scope of the Obligations for General-Purpose AI Models established by AI Act
On 18 July 2025, the European Commission published detailed Guidelines on the scope of the obligations for providers of general-purpose...
Sharan Murugan
Jul 193 min read
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EMA’s AI Journey: The Rise of Artificial Intelligence in Medicines Regulation
In a world where artificial intelligence (AI) is moving rapidly from theory to practice, regulators are tasked with keeping pace—not only...
Sharan Murugan
Jul 193 min read
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Meet ELSA: USFDA Launches Agency-Wide AI Tool to Optimize Performance
What if the agonizing wait for drug approvals could be slashed from days to minutes? Imagine a future where breakthrough therapies reach...
Sharan Murugan
Jun 22 min read
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USFDA Announcement: Shortening the Drug Approval Process- Integration of Generative AI by June end & Completion of First AI-Assisted Scientific Review
The U.S. Food and Drug Administration (FDA) has marked a significant milestone in its digital transformation journey by announcing the...
Sharan Murugan
May 132 min read
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