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USFDA Guidance: Use of Artificial Intelligence To Support Regulatory Decision & Guiding Principles of Good AI Practice in Drug Development
Artificial Intelligence (AI) is no longer a future concept in pharmaceutical research—it is already influencing how drugs and biological products are discovered, developed, manufactured, and monitored throughout their lifecycle. However, when AI outputs are used to support regulatory decisions , questions of trust, transparency, and accountability become critical. Recognising this, global regulators have begun defining expectations for the responsible use of AI in drug devel

Sharan Murugan
Jan 313 min read


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 8, 20252 min read


EMA Network Data Steering Group workplan 2025-2028: Leveraging Data and AI for Enhanced Medicine Regulation
In the evolving landscape of medicines regulation, data and artificial intelligence (AI) have become pivotal tools to enhance public and...

Sharan Murugan
May 11, 20253 min read


Announcing Veeva AI: A Bold Leap Toward Intelligent Automation in Life Sciences
The world of pharma and life sciences is abuzz with a major announcement: Veeva Systems has just unveiled Veeva AI , a groundbreaking...

Sharan Murugan
Apr 29, 20253 min read


Free 50+ Pharma eBOOKS
Hi Guys! You have been my supporters and wellwishers from the day I published this website. As you have been supportive of me from day...

Sharan Murugan
Dec 31, 20212 min read
