Standards & Regulation

Despite controversies, Robert Califf will finally take the reins at the FDA.

Does incentivizing informants deter off-label drug marketing ? Should other countries follow suit?

The stability of drug formulations is essential. But what should be monitored – and how often?

Neonates have been underserved, potentially missing out on life-giving scientific advances.

Regulators come down hard on facilities that come up short.

The UK Competition and Markets Authority (CMA) has handed out a £37.6 million fine to GSK for paying out “value transfers totaling over 50 million pounds” to competitors between 2001 and 2004 to delay the introduction of generic versions of its branded anti-depressant drug, Seroxat (paroxetine).

The Morphologi G3-ID can be used to generate component-specific particle size and shape data required to aid the reverse engineering of solid oral dose formulations. Here, we provide an example case study for a powder formulation.

A personal experience led us to examine how adverse drug events data can be used to benefit the industry.

The serialization deadlines are coming. It may seem an age away, but preparing for serialization is not as straightforward as you may think. Do you really want to get left behind?

The final deadline for the European Union’s REACH regulation is approaching – and the home stretch will be the most challenging, especially for pharma companies that have failed to recognize their role.