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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

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Step Status
Educational Content ✘
Posttest ✘
Evaluation ✘
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.
Objectives:
  • 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