Standards & Regulation

Addressing the opioid crisis, 3D printing drug guidelines, and execution drugs…

The US regulatory agency has enlisted other authorities in Europe to carry out inspections.

Sitting Down With… Margaret Hamburg, President-elect AAAS, Foreign secretary of National Academy of Medicine

EMA relocation, a price-fixing scandal, and FDA warning letters… What's new for pharma in business?

The EFPIA highlights the risks of disrupting UK–EU medicine supply chains.

Researchers find significant variation in regulation of pharmaceutical market systems in the developing world

How harmonization and international standards bodies bind trade and regulation in the pharma industry

In certain areas, there is significant disharmony across the ICH regions…

Margaret Hamburg, former FDA Commissioner, has led the agency through a period of increasing globalization.

Globalization has created an industrywide demand for regulatory harmonization. But who benefits?