Issue Date: September 20, 2006
Issued by: Center for Drug Evaluation and Research
Topic(s): Labeling
Status: Draft
Public Availability of Labeling Changes in “Changes Being Effected” Supplements
This guidance announces to holders of a new drug application (NDA), an abbreviated new drug application (ANDA), or a biologics license application (BLA), who intend to submit a “Changes Being Effected” supplement (CBE supplement) to make a postapproval labeling change, that FDA will make labeling revisions identified in a CBE supplement publicly available upon receipt of the supplement by FDA. This guidance does not have any bearing on supplements that relate to chemistry, manufacturing, and controls changes.
Download the Guidance Document
