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 »
The FDA has taken another step towards realizing their vision for encouraging pharmaceutical quality management practices. FDA’s Center for Drug Evaluation and Research (CDER) has developed
FDA Encourages Industry to Achieve Quality Management Maturity (QMM) Read More »
This month we celebrate 18 years of Axendia’s contributions to the life sciences industry. Since our inception, Axendia has continuously demonstrated exceptional dedication and innovation
Axendia’s Remarkable 18-Year Journey as Trusted Advisors to the Life Sciences Industry Read More »
A common misconception in the Medical Device industry is that FDA is impossible to interact with and that they have no interest in working with
TAP to Break the Stigma of FDA’s Inaccessibility Read More »
We’ve all heard the term nanotechnology thrown around, but what does it actually mean? Nanotechnology is the use of materials that exist on the nanometer
Big Things Come in Small Packages: FDA’s Approach to Nanotechnology Read More »
FDA’s Center for Drug Evaluation and Research (CDER) recently released its fifth annual report on the State of Pharmaceutical Quality. It reviews the state of
FDA Reports on the State of Pharmaceutical Quality Read More »
Axendia Analysis of “Successes and Opportunities in Modeling & Simulation for FDA” The last thing you want is to lag your regulator and in the
FDA Is Using Modeling & Simulation. Why Aren’t You? Read More »
FDA’s Position Paper on Distributed Manufacturing and Point-of-Care Manufacturing Throughout literature and movies, there is a trope that sufficient strife will produce sufficient innovations to
Manufacturing Innovations To Overcome Dire Situations Read More »
Computer Software Assurance for Production and Quality System Software The FDA has recognized that current perceptions and approaches to computer system validation (CSV) are a
FDA Releases New Draft Guidance on CSA Read More »
FDA’s Proposed Guidance on Conducting Remote Regulatory Assessments Remote. Remote. Remote. Since the COVID-19 pandemic started in 2020, this is the word we now use
FDA Remote Regulatory Assessments Are Here To Stay 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 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 »
