Issue Date: January 1, 2001
Issued by: Center for Drug Evaluation and Research
Topic(s): Chemistry, Manufacturing, and Controls (CMC)
Status: Final
Changes to an Approved NDA or ANDA: Questions and Answers: Guidance for Industry
This document provides questions and answers relating to the guidance on Changes to an Approved NDA or ANDA (the guidance).2 The questions are based on those posed to CDER by applicants. The questions and answers are presented using subject headings that correspond to the table of contents in the guidance
Download the Guidance Document
