US FDA’s Machine Learning Analysis Suggests Where To Look For Manufacturing Site Quality Problems
Executive Summary
XGBoost model sees site complexity contributes to quality risk, but misses device-related issues, says third FDA pharmaceutical quality report.
You may also be interested in...
The Quality Lowdown: Corporate Culture And Site Complexity Can Pose Challenges
Quality and the measure of a firm: Toyobo’s particulates and resins, Galenicko’s sanitation, Breckenridge’s product chemistry and Fujifilm’s cross-contamination risk.
US FDA Investigating Auto-Injector Problems With Copaxone Generics
Reports of bent needles and injector failures also raise questions about the FDA’s complex product approval process.
US FDA's First-Ever Countrywide Import Alert For Drugs Bans Mexican Hand Sanitizers
Move reflects agency’s growing frustration over deadly methanol adulteration, puts onus on Mexican manufacturers to prove safety and efficacy.