Standards & Regulation

How can the FDA tackle the inspection backlog?

Sputnik V (finally and definitely) starts rolling review with the EMA.

How to add value and reduce risks with ethics.

We have vaccines. Now, pharma’s mission is to address novel variants. And vaccine hesitancy.

Cell and gene therapy manufacturing technologies and methods are advancing rapidly, but can regulators keep up?

Vaccine development for COVID-19 may have been rapid, but no one has scrimped on safety.

Patient perspectives can make a huge difference when designing drug delivery devices that are truly fit for real-world use.

Is the European Union better prepared for future healthcare crises?

New EU “transparency” measures give member states the power to block vaccine exports if manufacturers can’t meet contractual obligations.

We sit down with the British Generics Manufacturers Association's Warwick Smith.