By Arif Noorani, Christopher Fanelli, David Ludlow, and Raj Pai, Sidley Austin LLP
We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an uptick in whistleblower complaints. Why? And how can you navigate it? This article examines the issue.
This article reviews the existing FDA programs impacting artificial intelligence (AI)/machine learning (ML) technologies in medtech, as well as the agency's priority list for releasing related guidances in 2023.
By Brandon Zurawlow, Principal Consultant at Containsure
Due to their complexity, combination products, specifically autoinjection systems, present unique challenges in implementing a container closure integrity testing strategy. Learn about these challenges and how to overcome them.