FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians. Interact with FDA staff from a variety of divisions and learn more about the FDA and drug regulation!
On Tuesday, March 23, 2021, CDER's Office of Communication, Division of Drug Information (DDI) hosted a webinar titled: FDA Drug Topics: The Ins and Outs of Prescription Drug Labeling. 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.
View Presentation Here: https://collaboration.fda.gov/pyxnt0aq64ht/
Download Presentation Slides: The Ins and Outs of Prescription Drug Labeling (PDF - 1.24MB)
Activity Outline and Continuing Education Information: The Ins and Outs of Prescription Drug Labeling (PDF - 159KB)
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