Standards & Regulation

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

When it comes to conducting clinical trials in emerging geographies, there are four key challenges to consider.

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?

Nominations are now open for The Medicine Maker 2021 Innovation Awards.

Is waiving patents for COVID-19 vaccines the right step forward?

A report suggests that more needs to be done to combat bleeding disorders. Is pharma playing its part in addressing this issue?