Australia Wants To Link Regulatory Review Of CDx And Associated Drugs
Executive Summary
Therapeutic Goods Administration proposals say the review of companion diagnostics and their corresponding drugs should be linked.
You may also be interested in...
Views Differ On Australian Proposal To Link Review Of CDx With Drugs
An Australian proposal to establish a regulatory framework for companion diagnostics has drawn a mixed response from pharmaceutical, biotech and medtech companies on issues like concurrent evaluation, product classification and unique identification.
Australia Wants To Link Regulatory Review Of CDx And Associated Drugs
Therapeutic Goods Administration proposals say the review of companion diagnostics and their corresponding drugs should be linked.
Moment Of Truth For Seven EU Filings; Cytokinetics To Make Its Case For Heart Failure Drug
The CHMP, the European Medicines Agency’s human medicines committee, will this week decide whether a range of new medicines merit being approved.