The Comprehensive In Vitro Proarrhythmia Assay: An Update
While the International Council on Harmonisation (ICH) S7B/E14 regulatory landscape has successfully prevented new drugs with an unrecognised propensity to…
Read more
Success with Adaptive Registries in Rare Disease Research
Clinical research in rare diseases has become intensely competitive, with stakes that are high both for sponsors and patients. Sean…
Working with the Regulators
Regulators such as the FDA and EMA are often perceived as roadblocks on the route to drug approval. Their role…
Developing Brown Fat Treatment for Tackling Obesity
Obesity has now reached epidemic levels worldwide. Consequently, there has been an alarming upsurge in major non-communicable diseases including type…
Draft Guidance Addresses Inclusion of Adolescents in Oncology Trials
With an eye toward helping industry, investigators, and institutional review boards (IRBs), the US Food and Drug Administration (FDA) has…
The Impact of the New European Union Medical Devices Regulation (EU MDR) 2017/745 and MDR 2017/746
The European Economic Area (EEA) – which includes the European Union (EU) and three of the four states of the…
Writing Pediatric Study Plans (PSPs) – The Impact of the Revised 2016 FDA Draft Guidance
Children make up approximately one-quarter of the world’s population, but despite this the majority of drugs used in children are…
Advantages and Challenges of Outsourcing Post-marketing Study Activities
In the past, life science companies went through numerous clinical trial phases before gaining market approval and launching their products.…
Clinical Trials in Russia – Report On 2017
Igor Stefanov at Synergy Research Group reveals that the Russian MoH approved 700 new clinical trials of all types including…
Transparency and Public Interest: Striking a Balance
As from next year, life sciences firms will be expected to prepare plainlanguage summaries (PLSs) for all Phase I–IV interventional…