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Omni Shoreham Hotel

Feb 23, 2017 7:00 AM - Feb 24, 2017 5:00 PM

2500 Calvert Street NW, , Washington, DC 20008 , USA

Advertising and Promotion Regulatory Affairs Conference

Session 2: FDA Draft Guidance and Initiatives

Session Chair(s)

Michael A. Sauers, RAC

Michael A. Sauers, RAC

Director, Global Regulatory Affairs - Advertising and Promotion

Eli Lilly and Company , United States

Hear directly from FDA’s OPDP on the two new draft guidances related to medical product communications. The agency will share their thinking on communication of health care economic information (HCEI) to payors about approved drugs, and their recommendations regarding communications to payors about investigational drugs and devices that are not yet approved or cleared for any use. FDA will also discuss the draft guidance concerning medical communications that include data and information that are not contained in a products’ FDA-required labeling, but that are consistent with the approved or cleared FDA-required labeling for the products. Finally, FDA will describe rulemaking efforts currently underway regarding the Patient Medication Information (PMI) Initiative led by the Office of Medical Policy Initiatives.


Catherine  Gray, PharmD


Catherine Gray, PharmD

FDA, United States

Director, Office of Prescription Drug Promotion, OMP, CDER

Elaine  Hu Cunningham, PharmD


Elaine Hu Cunningham, PharmD

FDA, United States

Sr. Regulatory Review Officer, OPDP, CDER

Elisabeth  Walther, JD, PharmD


Elisabeth Walther, JD, PharmD

FDA, United States

Regulatory Counsel

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