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The U.S. Food and Drug Administration has just made it official: your excuses for clinging to outdated systems because of antiquated validation practices are gone.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 »
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 »
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 »
