The Role of Clinical Monitoring in the Success of Medical Device Trials in the USA
Clinical monitoring is an indispensable component of the medical device industry, ensuring trials are conducted with precision, adherence to regulatory standards, and the safety of all participants. In the USA, where the regulatory landscape for medical devices is among...
The Role of Human Factors in Medical Device Usability Testing
Medical devices play a critical role in modern healthcare, saving lives and improving the quality of life for millions. However, their success is not solely dependent on advanced technology. Equally important is how users – whether healthcare professionals, patien...
Mastering New Labelling Regulations: Essential Guide to Medical Device Manufacturers
In the ever-evolving medical device industry, regulatory compliance is critical for ensuring patient safety and maintaining market access. Among the most significant updates are new labelling regulations, which affect how manufacturers present product information. These...
Pharma/Biotech – USA, Europe and Asia Regulatory Updates Roundup – Oct 2024
USA
FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer
The Food and Drug Administration approved nivolumab (Opdivo, Bristol Myers Squibb Company) with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent niv...
Medical Devices – USA, Europe and Asia Regulatory Updates Roundup – Oct 2024
USA
Guidance on Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
The guidance provides a framework for determining whether, and what type of, long-term neurologic, sensory, and developmental evaluations may be usefu...