The Ins and Outs of Prescription Drug Labeling
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
Additional Resources: Slides
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