The FDA’s New Chapter
Life Sciences Strategies for Adapting Under Dr. Marty Makary’s Leadership in 2025 and Beyond! As a Sr. Industry Analyst who closely tracks the pulse of […]
The FDA’s New Chapter Read More »
FDA
FDA is Challenging You to Democratize and Demystify AI
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 »
FDA Shares Approach to Regulating AI: What Life Science Companies Need to Know
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 »
FDA Defines Key AI Terms for Industry: Releases AI and Digital Health Glossary
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 »
Empowering Life Sciences: The Role of NIST’s AI Risk Management Framework to Drive Innovation
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 Proposes AI Lifecycle Management Framework
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 »
Nanomaterials Provide Near-Limitless Possibilities for the Advancement of Medical Devices and Pharmaceuticals.
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
How to Drive Accelerated Adoption of Advanced Manufacturing in the Medical Device Industry: Lend Your Voice!
The Medical Device Innovation Consortium (MDIC), in partnership with Axendia, Inc. is conducting a research survey seeking to uncover the internal and external barriers medical device companies must overcome
FDA on Artificial Intelligence Across the Product Lifecycle
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 »
4 Years Ago We Entered the Age of Continuous Disruption
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 »
Incentivizing Pharmaceutical Manufacturing Excellence
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 »
At FDA, The Future Is Already Here
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 »