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Advertising and Promotion Regulatory Affairs Conference


Session 2: FDA Draft Guidance and Initiatives

    Session Chair(s)
      Wayne L. Pines

      Wayne L. Pines

      • President, Regulatory Services and Healthcare
      • APCO Worldwide Inc., 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)
      Catherine B. Gray, PharmD

      Panelist

      Catherine B. Gray, PharmD

      • Management Advisor, Office of Prescription Drug Promotion, OMP, CDER
      • FDA, United States
      Sheila  Ryan, PharmD, MPH

      Panelist

      Sheila Ryan, PharmD, MPH

      • Regulatory Health Project Manager, OPDP
      • FDA, United States
      Elizabeth  Pepinsky

      Panelist

      Elizabeth Pepinsky

      • Health Science Policy Analyst
      • FDA, United States
      Kemi  Asante, PharmD, MPH, RAC

      Panelist

      Kemi Asante, PharmD, MPH, RAC

      • Health Science Policy Analyst
      • FDA Office of Prescription Drug Promotion, United States

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