DIA 2018 Global Annual Meeting

Combination products in the US are becoming mainstream in the healthcare industry. While there are a number of resources focusing on premarket and post-market requirements for combination products, the requirements for labeling, advertising and promotion are often neglected or under-emphasized.Labeling requirements for combination products (including advertising and promotion) are dictated by the product’s primary designation (i.e. drug, device or biologic). However, there are nuances unique to combination products that companies must consider, especially for companies expanding from a traditional pharma or device platform to combination products. Aside from different requirements, there are also different philosophies in how each industry develops labeling and the development of claims for use in advertising and promotion. Many combination products are intended for “home-use”. Health literacy and human factors are critical to the labeling process for these products. How should manufacturers practically address human factors in its product labeling? What about individually packaged devices intended to be used with an individually packaged drugs; or co-packaged combination products? - what is cross-labeling and how can it be practically managed? Do co-packaging products impact labeling? And, what opportunities the future of devices references drugs and cross-labeling may bring. Case examples will be presented, and a panel of experts share their experiences and answer audience questions. This session will be interactive and audience participation is highly encouraged.