Turin, January 11th 2024 – Corion Biotech requested an INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs (INTERACT) meeting for products at early development stage with Food and Drug Administration (FDA).
Corion Biotech obtained an initial and nonbinding advice regarding chemistry, manufacturing and controls (CMCs), pharmacology and toxicology program of CB-ChMF-11. The overall positive feedback was received in particular for the proposed development approach of the product for the treatment of severe very early-onset Preeclampsia.