Risk management needed for nano medical technology, says senior devices expert
This article was originally published in Clinica
Executive Summary
A comprehensive and systematic risk management-based approach, rather than a prescriptive regulatory approach, is essential for the future development and success of nano-and other novel medical technologies both from the point of view of promoting innovation and of safeguarding public health. That is the view of Richard Moore, manager, nanomedicine and life sciences, at Europe's major nanotechnology information centre, the Institute of Nanotechnology (IoN), based in Scotland. Mr Moore, has only recently joined the IoN, after working as director of science and innovation at the European medtech industry association, Eucomed, for nearly 10 years. He was previously with the European Committee for Standardisation as project manager, healthcare, for six years before taking up the Eucomed job, and told Clinica that he is "glad that he can offer his expertise in medical nanotechnology to the institute". He sees many challenges ahead in this field where technological progress is leaping ahead, with regulation struggling to keep up. Understanding the real risks associated with these products is proving complex.
You may also be interested in...
Keep Makena Under Accelerated Approval Pending More Studies, AMAG Tells US FDA
AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.
World-First Nod For Yuhan's Lung Cancer Drug, In Korea
The leading Korean pharma firm’s oral, third-generation EGFR-TKI is approved in the country, providing a new option for patients with advanced NSCLC and increasing hopes for global approvals given an ongoing global Phase III combination trial led by partner J&J.
DePuy Synthes Gains US FDA Clearance For Velys Robot For Total Knee Surgery
DePuy Synthes expects its Velys robotic-assisted system to be cost-effective, easy-to-use and to be well-suited for use in ambulatory surgery centers.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: