Our most recent paper on the types of drug labeling is a useful primer for anyone with labeling or safety surveillance responsibility.
Included are descriptions and references to the regulatory bases for Professional Labeling, FDA Approved Patient Labeling, Medication Guide, Consumer Medical Information, and Drug Facts Labeling, etc.
Understanding the various categories of FDA regulation is critical in maintaining compliant and current labeling. While this paper is a quick read, it provides clarity in distinguishing between the various types of labeling as well as a ‘checklist’ of all labeling that needs to be considered when changing one type or another.
Click here to access the paper or here to contact PDG for assistance with your drug or medical device labeling changes.