On May 8, 2025, the U.S. Food and Drug Administration (FDA) announced a historic milestone: the completion of its first AI-assisted scientific review pilot. Additionally, […]
From Pilot to Policy: FDA’s AI Transformation Hits Fast Forward Read More »
On May 5, 2025, an executive order titled “Regulatory Relief to Promote Domestic Production of Critical Medicines“ was signed by the administration. The order seeks
Strengthening Domestic Pharmaceutical Manufacturing in the Age of Continuous Disruption Read More »
ETQ Briefing Note Axendia was recently briefed by the executive team at ETQ, part of Hexagon, including Chris Nahil, Analyst Relations, Maureen Pienta, CMO and
Empowering Quality-Driven Innovation Read More »
From Simple Prompts to Autonomous Systems Artificial intelligence is driving a significant transformation in quality management. Quality management is evolving from basic command-based interactions into
The Evolution of AI in Quality Management Read More »
Life Sciences Strategies for Adapting Under Dr. Marty Makary’s Leadership in 2025 and Beyond! As a Sr. Industry Analyst who closely tracks the pulse of
The FDA’s New Chapter Read More »
Sware Briefing Note Axendia was recently briefed by the executive team at Sware, including Ellen Reilly, CEO, Bryan Ennis, Co-founder and Chief Quality Officer, Colleen
From Paper to Cloud: The Digital Transformation of Validation in Life Sciences Read More »
Are You Ready to Accept the Agency’s Challenge? FDA is taking a step to advance the integration of Generative Artificial Intelligence (GenAI) into healthcare by
FDA is Challenging You to Democratize and Demystify AI Read More »
Axendia was recently briefed by Erez Kaminski, founder and CEO of Ketryx. After leading AI initiatives at Amgen, Kaminski saw firsthand how legacy systems hindered innovation.
Transforming Lifecycle Management Read More »
ValGenesis Briefing Note Axendia was recently briefed by the executive team at ValGenesis. Participants included Jeff Russell, VP of Customer Success & Growth, David Medina,
Powering Smart Manufacturing in Life Sciences Read More »
The integration of artificial intelligence (AI) and machine learning (ML) into health care and biomedicine is transforming the industry by enhancing diagnostics, treatment planning, and
FDA Shares Approach to Regulating AI: What Life Science Companies Need to Know Read More »
NIST recently released the Artificial Intelligence Risk Management Framework: Generative Artificial Intelligence Profile (NIST-AI-600-1). This framework was developed to assist organizations in identifying the specific
FDA’s Troy Tazbaz, Director, and John Nicol, PhD, Digital Health Specialist at the FDA’s Digital Health Center of Excellence (DHCoE), recently proposed “A Lifecycle Management
FDA Proposes AI Lifecycle Management Framework Read More »
