Standards & Regulation

The technology behind cleanrooms is well over 50 years old. Is it time for a makeover?

Researchers call for more oversight as some pharma companies cozy up to hemophilia patients.

The world’s most populous state is set for big things in patented (bio) pharmaceutical development.

We should look to Warning Letters – and the subsequent solutions – to benefit from the blunders of others.

Packaging components can leach into drug products and become foreign impurities. Guidelines exist for the testing of drug products for elemental impurities, but how are these applied to elemental impurities derived from drug product packaging?

Will future drugs in Europe be priced based on therapeutic outcomes?

How difficult is it to develop a new drug? Statistics have the answer

The EMA says it will review its standards for first-in-human trials

Automated image analysis has been combined with Raman spectroscopy to achieve component-specific size and shape analysis of active ingredients, supporting and accelerating the commercialization of both innovator and generic pharmaceutical products.

Astronomers Chris Leigh and Mike Merrifield debate how a potential Brexit might impact UK science