SUPAC-transdermals draft requires prior approval supplement for rate-control layer change.
Executive Summary
SUPAC-TDS DRAFT REQUIRES SUPPLEMENTAL REPORT FOR RATE-CONTROL LAYER CHANGE, a material change in the layer's specifications, regardless of vendor. The change will require an in vitro/in vivo correlation or bioequivalence study, stability data and the attainment of functional requirements to be in accordance with the draft materials for the Scale-Up and Post-Approval Changes Guidance for Transdermal Drug Delivery Systems.