Advertising and Promotion Regulatory Affairs Conference

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 FDA will also discuss the draft guidance concerning medical communications that include data and information that are not contained in a products’ FDA-required labeling, but that are consistent with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.