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This webinar will provide an overview of the upcoming changes to the Office of Prescription Drug Promotion’s (OPDP) Core Launch Review process. The updates to the Core Launch Review process are designed to improve efficiencies, maximize use of FDA’s resources, provide timely feedback to firms, and support our mission to help ensure prescription drug promotion is truthful, balanced, and accurately communicated.

LEARNING OBJECTIVES

• Identify promotional materials that qualify for Core Launch Review within the OPDP Advisory Process
• Understand the changes to the Core Launch Review process and incorporate those changes into existing promotional material development strategies
• Utilize the various resources provided by OPDP to support the Core Launch Review process

INTENDED AUDIENCE

• Ad/Promo Regulatory Operations Managers
• Ad/Promo Submitters
• Ad/Promo Publishers
• Ad/Promo Consultants

FDA SPEAKER

Susannah O’Donnell, MPH, RAC
Reviewer Team Lead
Office of Prescription Drug Promotion | CDER | FDA

FDA RESOURCES

1. Final Guidance - Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs
2. Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs
3. Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers
4. OPDP website FAQs