Standards & Regulation

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?

The EMA is looking for individuals to join its scientific advisory groups.

AAM calls for policies in the US that encourage greater use of biosimilars.

Fake COVID-19 treatments and vaccines are abound – but the FDA is on the case.