Standards & Regulation

The details and reactions behind a recent FDA investigation into the cancer-risk of CAR-T therapies

How do we encourage the development of new cell and gene therapies without compromising our ethics?

Countries that struggled to acquire COVID-19 vaccines have not forgotten the inequity, and are reminding pharma giants that they shouldn’t either

A deep dive into the dangers of fentanyl entering the US supply chain – and the importance of the Drug Supply Chain Security Act

It’s official: CRISPR medicines are here as UK authorizes exa-cel.

Never underestimate the meticulousness with which authorities operate or the standards that businesses are expected to adhere to.

A look at cGMP deviations in recent warning letters, including manufacturing conducted in corridors and equipment uncleaned for 14 years.

Is renting material handling equipment the best way to help manufacturers tackle waste?

US-based law and patenting experts offer their thoughts on IP protection in the digital age

I explore recent cases of pediatric cough medicines contaminated with diethylene glycol.