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FDA investigators found API production records all over the floor, desks and cabinets of the quality unit in Yibin Lihao Bio-technical’s Sichuan, China facility. Read More
Post-inspection Official Action Indicated (OAI) classifications by CDER and CBER have dropped sharply in recent years, according to the latest data from the FDA’s Inspection Classification Database. Read More
The Government Accountability Office (GAO) laid out policy options for dealing with the challenges of machine learning in drug development in a report released yesterday — noting that uncertainty about potential regulation of machine learning is hindering its adoption. Read More
Therapiva Private, an active pharmaceutical ingredient manufacturer in India, was hit with a Form 483 by the FDA for quality control unit and cleaning lapses. Read More
The World Health Organization (WHO) and international regulators including the FDA have launched a pilot program for joint GMP inspections of sterile drug manufacturers. Read More
Health insurers filed a class action suit against Gilead in a Florida federal court accusing it of anticompetitive behavior over its HIV treatments. Read More