Barth syndrome (BTHS) is a paediatric-onset, ultra-rare disease characterised by cardiac abnormalities that can result in various health challenges, including an enl...

Medical interventions increasingly involve the use of technology and devices. New treatments may involve a medical device, combination product or in vitro diagnostic...

In the highly regulated pharmaceutical and biotechnology industries, quality management serves as the bedrock for ensuring product safety, efficacy, and regulatory c...

Over the last 25 years, the way we write regulatory documents has evolved – from lean writing to technology that aids in populating the reports we write, things have...

A new survey of senior US regulatory professionals has confirmed a direct correlation between unsustainable regulatory workloads and planned AI investment. That’s as...

The clinical trial industry is essential for ensuring the safety and efficacy of new medicines; however, it is also a significant contributor of greenhouse gas emiss...

Pharmaceutical and clinical research sponsors (clients) have long outsourced clinical development work, utilising both full-service contract research organisations (...

Malaria continues to have a significant impact on half of the world’s population who live in tropical regions. It claims 600,000 lives each year, the majority of who...

There is increasing, and necessary, attention on an open secret: the epidemic of steroid-toxicity. We sat down with Dr. John Stone, Professor of Medicine at Harvard ...

There is ongoing and increasing interest in using digital health technologies (DHTs) in clinical trials for clinical endpoints. By changing the yardstick by which ou...