“The regulatory uses of AI are real: In 2021, more than 100 drug and biologic applications submitted to the FDA included AI/ML components. These submissions …
Artificial Intelligence has the Attention of Regulators Read More »
The FDA is taking another step towards realizing the vision for pharmaceutical quality in the 21st century. To increase transparency and incentivize investment in mature …
FDA to Rate Industry on Quality Management Maturity Read More »
Debunking Industry Myths on Regulatory Science 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 »
10 years ago, Congress provided FDA the statutory authority to conduct risk-based inspection, with the promulgation of the FDA Safety and Innovation Act (FDASIA). The …
Quality Metrics Support Improved Quality Across the Value Network Read More »
By: Jared N. Matlis, Research Assistant Preparedness is a skill which is necessary for success in any situation, whether it is a job, schooling, or …
3D Printing Capacity Critical in Preparing for a Pandemic 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 »
Recap of the Institute of Packaging Professionals (IoPP) – Puerto Rico Chapter Meeting On August 22, 2019, I was invited by the IoPP – Puerto …
What to Expect in FDA’s Draft Guidance on Computer Software Assurance Read More »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 …
