Standards & Regulation

Regulators are driving serialization and tamper-evident packaging initiatives, but is the pharma industry fully primed to defend against counterfeits?

The EMA fights to reinstate its former executive director – and the FDA’s new leader is still unconfirmed

Expedited regulatory approvals bring medicines to market faster – but are they the right drugs?

Dissecting a ligand into smaller fragments can provide a strategy for analyzing the role of key functional groups in a protein-ligand interaction.

It is well established that the use of nanotechnology in medicine and more specifically drug delivery is spreading rapidly.

Abusers are finding ways to circumvent current abuse-deterrent measures, leaving companies in need of new strategies.

Lawrence (Larry) Lesko is a bioanalytical veteran with many years of academic and FDA experience under his belt.

Prescription drug abuse has already reached epidemic proportions in the US – and other countries look set to follow the dangerous trend.

How did the NIH get it so wrong – and how can it move on?

Pharmaceutical and regulatory professionals around the world must speak the same language.