While the International Council on Harmonisation (ICH) S7B/E14 regulatory landscape has successfully prevented new drugs with an unrecognised propensity to induce the...

Clinical research in rare diseases has become intensely competitive, with stakes that are high both for sponsors and patients. Sean Kennedy at Syneos Health describes...

Regulators such as the FDA and EMA are often perceived as roadblocks on the route to drug approval. Their role is not to make life for drug developers difficult, as t...

Obesity has now reached epidemic levels worldwide. Consequently, there has been an alarming upsurge in major non-communicable diseases including type 2 diabetes, non-...

With an eye toward helping industry, investigators, and institutional review boards (IRBs), the US Food and Drug Administration (FDA) has unveiled draft guidance on t...

The European Economic Area (EEA) – which includes the European Union (EU) and three of the four states of the European Free Trade Association (EFTA) – has long been c...

Children make up approximately one-quarter of the world’s population, but despite this the majority of drugs used in children are usually prescribed ‘off-label’ and h...

In the past, life science companies went through numerous clinical trial phases before gaining market approval and launching their products. Once those products were ...

Igor Stefanov at Synergy Research Group reveals that the Russian MoH approved 700 new clinical trials of all types including local and bioequivalence studies during 2...

As from next year, life sciences firms will be expected to prepare plainlanguage summaries (PLSs) for all Phase I–IV interventional trials, to comply with requirement...