About this document
CMC Postapproval Changes for Annual Reports by ldelvall is a document available to read on EtoBox.
This guidance from the FDA outlines the recommendations for documenting postapproval manufacturing changes in annual reports for new drug applications (NDAs) and abbreviated new drug applications (ANDAs). It specifies that certain low-risk changes can be reported in annual reports instead of requiring supplemental applications, aiming to streamline the reporting process while ensuring product quality. The document includes examples of changes and emphasizes the need for risk-based evaluations to determine t
- Author
- ldelvall
- Language
- EN