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 »
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 »
Axendia’s 2024 Life Sciences Industry Radar Axendia unveiled its fifth annual Life Science Industry Radar on February 15, 2024, during a live “Straight from the Source”
Plotting a Course to Success in the Age of Price Negotiations Read More »
An Axendia “Straight from the Source” Event Axendia revealed its 2023 Life Sciences Radar on February 2, 2023, during a live event. Members of our
Life Science Industry Predictions for 2023 and Beyond! Read More »
Debunking Industry Myths on Advanced Manufacturing For FDA, Advanced Manufacturing means an approach for the manufacturing of pharmaceutical, biologics, and devices that incorporates novel technology,
FDA is Encouraging Advanced Manufacturing – Are YOU Ready? Read More »
Debunking Industry Myths on Regulatory Science FDA is moving Regulatory Science into the 21st century. To this end, the Agency is driving innovation of tools,
FDA is Moving Regulatory Science into the 21st Century, Are You Ready? Read More »
To help you navigate, Axendia will reveal its 2022 Life-Sciences Radar in this episode of our Straight from the Source series. Axendia’s analyst team will
Plot a Course to Success in the Age of Continuous Disruption! Read More »
Automating Electronic Batch Record review is a key benefit of Modernizing Manufacturing Operations. Yet concerns regarding FDA’s acceptance of Review by Exception (RBE) has prevented
FDA Debunks Industry Myths on Electronic Batch Records and Review by Exceptions Read More »
Industry must adapt and overcome current and future disruptive trends on the horizon. To assist in this effort, Axendia revealed the 2021 Life-Sciences Radar. In
2021 Forecast for the Life Sciences Industry Read More »
The FDA has recognized that current perceptions and approaches to computer system validation (CSV) are a significant barrier to Digital Transformation and Manufacturing Modernization. The
FDA Shares Insights on Digital Transformation & Manufacturing Modernization Read More »
An Axendia Straight from the Source Webinar Disruption is on the radar! Life-Science executives must plot a course for success. That was the theme of
2020 Life Science Radar – Webinar Registration is Open! Read More »
A Straight from the Source Webinar The interest in 3D Printing (a/k/a Additive Manufacturing) has risen spectacularly the last decade. The use of 3D Printing
FDA Discusses Challenges and Opportunities for 3D Printing in Life Sciences Read More »
