Standards & Regulation

Despite efforts to round up counterfeit criminals, fake medicines still find their way into supply chains.

Serialization is far from simple, and many companies overlook key aspects

The US and and EU deadlines are approaching, but is the industry ready for serialization?

The FDA approval of Kymriah marks the first CAR-T cell-based gene therapy available in the US

Data integrity is an important part of pharma, but not everyone knows how to handle it

We need to stop companies from using loopholes to sell unproven cell therapies to desperate patients

Are you compliant with the new guidelines for elemental impurities? There’s only six months left to get up to speed.

Joint letter from eight trade associations warns of “supply disruptions to life-saving medicines.”

The FDA aims to reduce drug prices with a more competitive market - and generics are key.

As Article 50's clock continues to tick, will the UK reconsider EEA/EFTA membership?