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Session 1: FDA Update - What’s New and What’s Worth Reiterating
Session Chair(s)
Wayne Pines
President, Health Care
United States
Catherine Gray, PharmD
Director, Office of Prescription Drug Promotion, OMP, CDER
FDA, United States
This session will feature senior representatives from CDER and CBER who will provide updates on recent FDA advertising and promotion activities, including compliance actions, process considerations, and goals for 2021.
Learning Objective : At the conclusion of this session, participants should be able to:
- Demonstrate a thorough understanding of recent compliance actions
- Identify best practices to construct and submit a Response to Compliance Action submission
- Identify roles of the different CBER branches in Office of Compliance and Biologics Quality Division of Case Management
- Explain best practices for communicating with your FDA colleagues
Speaker(s)
OPDP Updates - Looking Back, Looking Forward
Catherine Gray, PharmD
FDA, United States
Director, Office of Prescription Drug Promotion, OMP, CDER
Speaker
Lisa Stockbridge, PhD
FDA, United States
Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER
Speaker
Deborah Wolf, JD
FDA, United States
Regulatory Counsel, OPEQ , Regulatory Policy, CDRH
Response to OPDP Compliance Actions in eCTD
Jason Cober, MPA
OPDP | OMP | CDER | FDA, United States
Lead Project Manager
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