More Countries Join US-EU Inspections Deal
Executive Summary
There are now just two European countries left to join the agreement between the EU and the US on recognizing the findings of inspectorates in each other’s jurisdictions.
You may also be interested in...
Germany Joins EU-US Inspections MRA
There is now only one country left to join the agreement between the EU and the US on recognizing the findings of inspectorates in each other’s jurisdictions.
Two More Member States Join US-EU Inspections Deal
The number of European countries whose drug manufacturing site inspections the US regulator can rely on in place of its own inspections has grown.
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.