Commission makes progress towards central IVD (in vitro diagnostic) database
This article was originally published in Clinica
Executive Summary
Another step has been taken towards the goal that will eventually put an end to the requirement for manufacturers to in vitro diagnostic products in each European country in which they wish to market them. The European Commission intends to present the first working version of a central IVD database for registration, known as EUDAMED, in November.
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: