News
ABX-CRO Successfully Completes FDA Pre-Approval Inspection for PET Radiodiagnostic
We are grateful for our team's dedication and this significant achievement. ABX-CRO is proud to announce the successful completion of an FDA pre-approval inspection for a PET radiodiagnostic with a biological pharmacophore in a global phase III clinical trial.
The inspection covered ABX-CRO's clinical trial conduct, data management, imaging core lab operations, and quality management systems. The successful outcome without critical findings confirms the robustness of ABX-CRO's GCP-compliant processes and the quality of our imaging and clinical data.
This milestone further validates ABX-CRO's capability to support radiopharmaceutical product registrations with major regulatory authorities, from early clinical development through to marketing authorization.