Standards & Regulation

The deadline for the US Drug Supply Chain Security Act is approaching.

Drug shortages are everywhere. We speak with Vimala Raghavendran at the US Pharmacopeia to get the full picture.

With open minds and open sources, the future is foundational – and bright.

Lecanemab is refused marketing authorization by the European Medicines Agency.

Fertility support programs for gene therapy Medicare patients are being blocked in the US.

Collaboration and thoughtful automation at scale will be critical for unlocking cell and gene therapies for patients

Why companies must tighten their supply chains in light of Chinese anti-espionage laws and other regulatory clampdowns.

Counterfeit deterrents are not yet available in some regions. We speak with Advanco CEO Alf Goebel to find out why.

Following on from deaths attributed to contaminated medicines, here’s how the US Pharmacopeia is promoting testing for DEG and EG.

Preparing for the EU’s new HTA regulation and Joint Clinical Assessment process