Regulatory Blog

Artificial intelligence (AI) is rapidly becoming an important part of healthcare, drug development, and regulatory operations. To modernize its internal systems and improve operational efficiency, the U.S. Food and Drug Administration (FDA) announced major upgrades to its AI infrastructure and data management capabilities. On May 6, 2026, the FDA announced the launch of Elsa 4.0, an upgraded version of its internal AI tool, along with the completion of a large-scale data plat

The global life sciences landscape is rapidly evolving with the integration of advanced artificial intelligence to accelerate drug discovery, genomics, and translational research . OpenAI has introduced a specialized model designed to address the complexity and scale of modern biomedical research workflows. The announcement Introducing GPT-Rosalind for life sciences research , published in April 2026 , presents a purpose-built AI model aimed at supporting scientific reasoning

I still remember sitting in the back of my chemistry class, flipping through massive textbooks just to compare atomic weights or understand a single element. A single question often meant turning dozens of pages. It was slow, and honestly, it sometimes took the excitement out of learning. Fast forward to today, and learning science has completely transformed. Instead of digging through hundreds of pages, we can now explore information instantly with interactive tools. That’s

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

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