Comment from Pathway for Patient Health

Summary: The Pathway for Patient Health Collaborative Community argues that the SUPAC guidance family should not be withdrawn without replacement or consolidation because it contains unique, product-specific quantitative frameworks and protocols not covered by ICH Q12 or the 2004 Changes guidance. They recommend specific consolidations and updates to preserve these "orphaned" contents while aligning with modern regulatory frameworks like ICH Q12 and ICH Q9.