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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research

The Ins and Outs of Prescription Drug Labeling

Step Status
Educational Content
Starts On: Fri, 3/4/22: 12:00 AM EST
Ends On: Tue, 12/31/24: 11:45 PM EST
Type: Enduring Material
Credits: 1
Description: This webinar discussed the different types of FDA-approved prescription drug labeling including carton and container labeling, patient-labeling (Medication Guides, Patient Package Inserts, and Instructions for Use), and the Prescribing Information; described the process for approval of the Prescribing Information; explained some key parts of the Prescribing Information; and discussed the similarities and allowable differences between generic drug labeling and labeling for a previously approved drug with the same active moiety or reference listed drug.
  • Identify the different types of FDA-approved prescription drug labeling
  • Discuss the process for FDA approval of prescription drug labeling
  • Describe the contents of selected parts of the Prescribing Information
  • Explain the differences between generic drug labeling and reference listed drug labeling
Additional Information: Review the Activity Announcement for additional details: Announcement Form
Additional Resources: Slides