Standards & Regulation

Collusion, pollution, and a pricing victory for pharma in California… what’s new in business?

The FDA consults stakeholders over plans to loosen restrictions on off-label drug marketing

Patients don’t always read drug risk information – even when they say they do

The EMA says “yes” to transparency, but some pharma companies have other ideas.

A consortium of vendors and pharma companies search for a single, serialization standard.

Are reduced GDUFA fees on the horizon for contract manufacturers?

This article explains how an inline probe was used to monitor a granulation at three different scales to confirm that, in each case, the granules produced were the same size, and more importantly produced tablets of identical quality as quantified by hardness.

Robust formulation and coating expertise are required to get the best results with continuous coating.

Sitting Down With… Akm Khairuzzaman, a 3D printing expert from the FDA.

Not all successful biosimilar applications in Europe follow guidelines to the letter