Generative AI (GenAI) technology is already transforming everyday regulatory and safety processes, thanks to its ability to digest, assess, and summarise key insights and findings from acro
Medical, legal and regulatory review (MLR review) of promotional as well as non-promotional materials is one of the core responsibilities of medical and commercial teams within any life sci
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has put out a call for developers of artificial intelligence as a medical device (AIaMD) technology to join its new regul
The FDA has declined to approve Vanda Pharma's tradipitant for delayed gastric emptying (gastroparesis), prompting a furious response from the company.
Elon Musk's Neuralink has been awarded breakthrough status from the FDA for an implantable chip – dubbed Blindsight – that promises to restore the sight of people with vision impairment.
Reviewing new international research, Peter Muller and Mike Baird of Schlafender Hase explore how Class 2 and 3 device manufacturers in Europe and the US are coping with rising Agency contr
A pharma company’s core mission is to improve patient outcomes. This hinges on effectively influencing HCP clinical behaviour and driving disease education.