Understanding the various types of drug product labeling is an essential component of maintaining labeling compliance. Our most recent paper describes the different types of Drug Labeling and includes reference to the regulatory basis for each.
Did you know that FDA considers a drug ‘label to be a separate and distinct entity than ‘drug labeling’? Do you know what Consumer Medication Information (CMI) or Patient Medication Information (PMI) is?
If you’re not sure as to the answers to these questions and have any responsibility for your drug product’s labeling, click here to access a paper on the topic or here to contact PDG for assistance with your drug or medical device labeling changes.