Canadian guidelines on post-NOC changes reflect new policy
This article was originally published in SRA
Executive Summary
Following extensive consultation with stakeholders, Health Canada has finalised a set of guidelines that reflect the authority’s new policy on reporting postapproval changes to drugs, biologics and radiopharmaceuticals1. The guidelines came into effect on 30 September.
You may also be interested in...
Global medtech alliance approves six new member associations
An emerging alliance of medical technology industry associations representing innovative companies that currently develop and manufacture 85% of the world's medical devices, diagnostics and equipment has approved the membership applications of six more associations, bringing the total number of members to 19.
Global medtech alliance approves six new member associations
An emerging alliance of medical technology industry associations representing innovative companies that currently develop and manufacture 85% of the world's medical devices, diagnostics and equipment has approved the membership applications of six more associations, bringing the total number of members to 19.
US FDA scrutiny of DTC genetic tests continues
The US FDA's devices unit has written to three genetic testing companies warning them that they may be marketing their products and services without clearance by the agency.