Are You Ready to Accept the Agency’s Challenge? FDA is taking a step to advance the integration of Generative Artificial Intelligence (GenAI) into healthcare by […]
FDA is Challenging You to Democratize and Demystify AI Read More »
The integration of artificial intelligence (AI) and machine learning (ML) into health care and biomedicine is transforming the industry by enhancing diagnostics, treatment planning, and
FDA Shares Approach to Regulating AI: What Life Science Companies Need to Know Read More »
The FDA has released a new Digital Health and Artificial Intelligence Glossary, designed to help clarify the increasingly complex terms used in the world of artificial
FDA Defines Key AI Terms for Industry: Releases AI and Digital Health Glossary Read More »
In 2005, we founded Axendia with a clear mission: to provide life sciences executives with more than business buzzwords, tech jargon, and regulatory constraints. We
Celebrating 19 Year of Axendia: A Journey of Trust and Innovation Read More »
NIST recently released the Artificial Intelligence Risk Management Framework: Generative Artificial Intelligence Profile (NIST-AI-600-1). This framework was developed to assist organizations in identifying the specific
FDA’s Troy Tazbaz, Director, and John Nicol, PhD, Digital Health Specialist at the FDA’s Digital Health Center of Excellence (DHCoE), recently proposed “A Lifecycle Management
FDA Proposes AI Lifecycle Management Framework Read More »
To encourage the use of Nanomaterials in medical products, the FDA published guidance for the industry on “Drug Products, Including Biological Products, that Contain Nanomaterials.” Given
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 »
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 »
