FDA
has issued a new guidance document: “Established Conditions: Reportable CMC
Changes for Approved Drug and Biologic Products - Guidance for Industry.”
This
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.
Posted by Tim Sandle
No comments:
Post a Comment
Pharmaceutical Microbiology Resources