The disparity between the availability of medical devices for paediatric and adult patients has recently sparked regulatory, academic, scientific, and economic debate in the United …

AI, or artificial intelligence, is one of the most hyped terms to emerge in technology over the past decade. Despite that hype, it does possess …

The data generated during the development of new medicines come in a wide range of formats and may be generated from a variety of sources. …

Clinical trials in therapeutic areas targeting rare diseases are riddled with operational difficulties, with patient recruitment being arguably the most challenging aspect. By definition, a …

Not all possible side-effects of a pharmaceutical drug or medical device can be anticipated based merely on preapproval studies. The FDA Office of Surveillance and …

All clinical trials come with inherent challenges. Sponsors must navigate an intricate web of regulatory issues, approval time frames,  operational complexities, and perhaps the greatest …

The EU Clinical Trials Regulation must be implemented directly into the law in the EU Member States, whilst Directives, such as the EU Clinical Trials …

When the US Congress authorised the FDA’s Tropical Disease Priority Review Voucher Program in 2007, it sought to spur development of drugs that prevent or …

In recent years, the pharmaceutical industry has seen tremendous changes in the way it is expected to deliver new drugs to market: being under increasing …

Rossen Mihaylov, Ramus Medical explores how to organise CT on medical devices in order for the sponsor and CRO to be able to operate as …