Regulatory Affairs Professionals Society

MedCon: FDA, industry experts discuss best practices for managing software defects, anomalies

The difference between an anomaly and a defect in product software can be confusing, but it is important to identify which is ...
RAPS

FDA warning letters address CGMP, clinical study plan failures

Intas Pharmaceuticals was again in hot water with the US Food and Drug Administration (FDA) for a host of current good manufacturing practice (CGMP) violations, including manipulating particle counts ...