The Quality Lowdown: What Happens When The US FDA Must Choose Between Risks
Executive Summary
Tuberculosis or cancer, sterility assurance or shortages, the choices come at you fast; Takeda, Wintac, Banco Vida updates.
You may also be interested in...
US FDA’s Machine Learning Analysis Suggests Where To Look For Manufacturing Site Quality Problems
XGBoost model sees site complexity contributes to quality risk, but misses device-related issues, says third FDA pharmaceutical quality report.
The Quality Lowdown: Yes, The US FDA Expects You To Heed Import Alerts And Testing Requirements
PCCA repackaged adulterated APIs, Allay failed to understand processes, ShangRao and Mexican firms peddled subpotent, sometimes methanol-tainted ethanol.
Nitrosamine Concerns Spur Precautionary Testing Of Rifampicin In EU
National regulators throughout the EU will ask manufacturers of rifampicin-containing medicines to check their products for nitrosamine impurities before they are released for sale.