EMA to Wait for More Experience Before Issuing Guidance on Companion Diagnostics
Known for its relatively relaxed regulation of companion diagnostics (CDx), guidance from the European Medicines Agency (EMA) is not expected until the agency gains more experience with these drug-device combinations, an expert says.
300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.
Phone (703) 538-7600 - Fax (703) 538-7676 - Toll free (888) 838-5578.
Copyright by FDAnews. All rights reserved. Do not duplicate or redistribute in any form.