Turning Innovation into Clinical Advantage for Faster Patient Access The process of biopharmaceutical clinical evidence development is undergoing dramatic change. Technological innovation, novel development strategies, […]
Accelerating Time to Market with Modern Clinical Evidence Strategies Read More »
Axendia’s Analysis of the Root Causes and Our Recommendations to Prevent Them There has been a lot of buzz around FDA’s warning letter which for
FDA Calls Out Inappropriate Use of Artificial Intelligence Read More »
The FDA’s remote regulatory assessments (RRAs) are no longer temporary pandemic measures. Over the past few years, the agency has made it clear that it
Is Your Lab Ready for the FDA’s Remote Data Access Era? Read More »
The U.S. Food and Drug Administration has just made it official: your excuses for clinging to outdated systems because of antiquated validation practices are gone.
FDA CSA Just Removed Your Excuses for Implementing Modern Technology Read More »
An Axendia “Straight from the Source” Episode Axendia’s Sandra K. Rodriguez sits down with Garth Conrad (Head of Quality, Flex Health Solutions) to cut through AI buzz and focus
Navigating AI’s Peril and Promise: The Executive Perspective Read More »
An Axendia “Straight from the Source” Episode In our latest episode, Daniel R. Matlis (President, Axendia) sits down with Ed Armstrong (VP of Quality, Vedanta)
Is AI in Quality an Evolution or a Revolution? Read More »
Artificial intelligence continues to transform life sciences, from accelerating drug discovery to improving patient diagnostics and optimizing manufacturing. But with great power comes great responsibility
ISO/IEC 42001:2023 – The AI Standard Life Sciences Can’t Afford to Ignore Read More »
An Axendia Industry Webinar Presented by Kalypso The future of MedTech is not on the horizon. It is happening now. Artificial intelligence is revolutionizing diagnostics,
Future-Ready MedTech: How to Capitalize on Industry Trends to Fuel Growth Read More »
FDA Expects That Records be Submitted in Electronic Format Nestled within FDA’s final guidance on Remote Regulatory Assessments (RRAs) is a pivotal and decisive statement:
Why Paper Won’t Cut It In FDA’s Remote Oversight Era Read More »
The FDA is embarking on a transformative journey—one that seeks to modernize regulatory processes, accelerate approvals, and address chronic disease trends in a proactive manner.
Commissioner Unveils Priorities for a New FDA Read More »
An Axendia “Straight from the Source” Episode In the debut episode of Straight from the Source, Axendia’s President Daniel R. Matlis and Senior Industry Analyst, Sandra
The Impact of the Most Favored Nation Pricing Executive Order Read More »
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 »
