Standards & Regulation

Is pharma keeping up with the latest innovations? US legislators say no, and are looking to a new act to accelerate approvals.

In this paper, the authors describe the use of laser diffraction to analyse dry powder behaviour.

The rise of biosimilars is great news for overburdened healthcare systems, but it’s a very different proposition to a simple generic.

In this white paper we examine the deformulation workflow, demonstrating the value of the technique of Morphologically Directed Raman Spectroscopy (MDRS) within this context.

But can pharma manufacturers do more to help prevent medication errors?

FDA scolds company for revealing interim trial results

Just how prevalent is pharmacogenomic information on European drug labels?

Is early and regular dialogue with regulatory agencies the key to success for smaller companies?

Research into rare diseases is on the rise, but are prices sustainable?

Serialization will enable our industry to take up its rightful place in the ‘Internet of Things’.