Standards & Regulation

Preparing for the EU’s new HTA regulation and Joint Clinical Assessment process

Why the FDA must delete its statement that people are not horses (or cows), referring to ivermectin use

In this video interview, Courtney Silverthorn explains the inspiration behind a free regulatory playbook for gene therapy manufacturers.

Production records written using erasable markers, use of expired raw materials, and more.

The Supreme Court will decide the fate of the abortion pill mifepristone in the US on March 26, 2024.

As incidents of DEG poisoning continue to occur, the IPEC Federation issues a call for companies not to be complacent when it comes to supply chains.

Three regulatory pathways for drug–device combinations – and why early action is key.

Introducing the British Standards Institution’s new environmental initiative to minimize antimicrobial resistance caused by manufacturing operations.

A drug development story: how one company filed a marketing authorization in Europe for a botanical drug to treat alopecia areata.

A look at the FDA’s safety investigation into CAR T therapeutics.