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
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
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