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

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 …

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

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industry, investigators, and institutional review boards (IRBs), the US Food and Drug Administration (FDA) has unveiled draft guidance on the …

The European Economic Area (EEA) – which includes the European Union (EU) and three of the four states of the European Free Trade Association (EFTA) …

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 have …

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

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 …

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 requirements …