Standards & Regulation

Pfizer-BioNTech COVID-19 vaccine receives full FDA approval.

Pharma wants to empower patients to make informed healthcare decisions, but patients also need to be protected from misinformation.

AI is expanding into medicine. Are the world’s regulators ready?

Sandoz’s Pierre Bourdage talks to us about biosimilars and how uptake can be boosted.

Advanz Pharma is fined for substantially hiking the price of a generic drug.

How can we ease the process of taking ATMPs to clinical trials? Two experts lay out the key considerations.

The EMA releases its annual report highlighting its achievements throughout 2020.

We sit down to interview Peter Marks, Director of the Center for Biologics Evaluation and Research at the US FDA.

Global regulators attended a virtual workshop on second generation COVID-19 vaccines – here’s what they talked about.

What role can regulators play in overcoming the barriers to the adoption of continuous manufacturing processes?