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Session 2: FDA Draft Guidance and Initiatives
Session Chair(s)
Wayne Pines
President, Health Care
United States
Hear directly from FDA’s Office of Prescription Promotion on the latest guidances related to medical product communications. The agency will share its thinking on communication of healthcare economic information (HCEI) to payers, as well as information for firms about how FDA evaluates firms’ medical product communications that present information that is not contained in the FDA-required labeling for the product, but that may be consistent with the FDA-required labeling for the product. The agency will also discuss the final guidance on product name placement in promotional labeling and advertisements for prescription drugs.
Learning Objective : At the conclusion of this session, participants should be able to:- Discuss the latest FDA guidances affecting medical product communications
- Recognize the FDA’s view on how to communicate with payers
- Explain the FDA’s view on communicating information that is considered consistent with the FDA-required labeling for that product
- Describe the FDA’s view on product name placement, size, prominence, and frequency in promotional labeling and advertisements
Speaker(s)
Panelist
Catherine Gray, PharmD
FDA, United States
Director, Office of Prescription Drug Promotion, OMP, CDER
Panelist
Sheila Ryan, MPH, RAC
FDA, United States
Acting Director, ODSIR, Division of Supply Chain Integrity, OC, CDER
Panelist
Elizabeth Pepinsky, JD
FDA, United States
Health Science Policy Analyst
Panelist
KEMI ASANTE, PharmD, MPH, RAC
FDA, United States
POLICY ANALYST