FDA发布指南草案阐释变更申报新思路 FDA Guidance Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products
The guidance describes those sections in a common technical document (CTD)- formatted application that typically contain information that meets the definition of established conditions, and provides considerations for managing and communicating changes to the approved established conditions over the lifecycle of an approved product.
This guidance is intended for applicants submitting original new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) to CDER and CBER.
