Standards & Regulation

Here’s a look at recent violations cited in FDA Warning Letters: fly pupae, cross contamination, trial dosing errors, and more.

Biopharma companies procrastinating on sustainability measures risk falling behind, according to Cytiva’ Global Biopharma Sustainability Review.

AstraZeneca’s FluMist is the first flu vaccine to be approved for self-administration.

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.