Standards & Regulation

Alcami experts discuss what’s needed to accelerate drug development.

EU-based associations voice concerns over joint clinical assessments and the lack of advice meetings.

How to meet the demand for first-in-human clinical trials using fit-for-phase formulation approaches.

The rocket-fueled dreams of a young engineer applied to the cleanroom industry.

Controversial and divisive, but Kennedy’s expertise is intended for one thing: change.

Claus Zieler from Astellas and EFPIA addresses the challenges facing innovation in Europe, including regulatory burdens and access to medicines.

We dive into the archive of 2018 for insight and inspiration – this time with Bruno Sepodes

Counterfeit medicines pose a significant threat to global health. A recent study uncovers alarming facts and emphasizes the need for solutions.

How the pharma industry can help tackle the opioid crisis and advance treatments

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