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 »
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 »
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 »
Q&A from an Axendia Straight from the Source (SftS) Webinar By: Francisco Vicenty, FDA, CDRH and Daniel R. Matlis, Axendia, President In our recent webinar, we
FDA Answers Your Questions on the New Approach to CSV Read More »
By: Thomas O’Connor, Division of Product Quality Research Director, US FDA FDA is committed to supporting and enabling pharmaceutical innovation and modernization as part of
FDA is Enabling Innovation and Modernization Read More »
A Straight from the Source Webinar Available On-Demand FDA is committed to supporting and enabling pharmaceutical innovation and modernization. The Agency recognizes that continuous manufacturing
FDA Shares Quality Considerations for Continuous Manufacturing Read More »
A Straight from the Source Webinar The FDA has recognized that existing perceptions and approaches to computer system validation (CSV) are a significant barrier to
FDA Shares a New Approach to CSV Read More »
