How Will It Affect You? The FDA has released a paper through its medical product centers to reaffirm its commitment to the responsible and ethical […]
FDA on Artificial Intelligence Across the Product Lifecycle Read More »
Are Black Swans STILL COLLIDING with YOUR Supply Chain Do you remember where you were on Friday, March 13, 2020? I don’t think I will
4 Years Ago We Entered the Age of Continuous Disruption Read More »
FDA’S CALL FOR INDUSTRY COLLABORATION In a pivotal move towards advancing the quality and efficiency of pharmaceutical manufacturing, the Food and Drug Administration (FDA) has
Incentivizing Pharmaceutical Manufacturing Excellence Read More »
FDA DIGITAL TRANSFORMATION SYMPOSIUM 2023 EVENT BRIEF “The future is already here- it’s just not evenly distributed,” declared William Gibson. Axendia published the “FDA’s e-Transformation
At FDA, The Future Is Already Here Read More »
Experts from IBM and Axendia shared the Journey to CSA in “Welcome to Wednesday” Maximo Event. FDA’s Computer Software Assurance (CSA) draft guidance is intended
Journey from Computer Software Validation (CSV) to Computer Software Assurance (CSA) Read More »
Comments Due by October 30, 2023 On September 19, 2023 FDA released its IT Strategy for FY 2024 – 2027. In 2009, Axendia completed a
FDA Announces IT Strategy for Fiscal Years 2024 to 2027 Read More »
“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 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 »
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 »
