Regulatory

The FDA is monitoring live clinical trial data using AI in a landmark pilot with AstraZeneca and Amgen. What real-time oversight could mean...

ICH E6 R3 has reset expectations for the Investigator's Brochure. What sponsors and medical writers need to know about safety reporting in...

The UK's biggest clinical trials reform in 20 years takes effect April 2026. What the new MHRA regulations mean for sponsors and trial...

How the FDA’s Plausible Mechanism Framework could transform personalised genomic therapies and treatment development for ultra-rare...

Discover how artificial intelligence is affecting medical writing, where its limits lie, and why human judgement remains critical for...

The EMA has approved Waskyra for Wiskott Aldrich Syndrome. A personal reflection on Niche's decade long role in this gene therapy's...

Having worked in early-stage clinical pharmacology for over 30 years

Concerns about readiness of the European Medicines Agency’s (EMA) Clinical Trials Information System persist as the deadline for...

The EUropean Federation for Exploratory MEdicines Development (EUFEMED

Metathesiophobia: from Preclinical to Clinical Development

Metathesiophobia: from Preclinical to Clinical Development

The first RASP-UK publication outlines a stratified medicine approach to severe asthma using biomarkers and personalised treatment...

Welcome everyone to the first issue of the Frailomic consortium