Roberta Hanson of Faegre Baker Daniels served as the symposium moderator and delivered remarks at the beginning of the program.
Attorneys Lee Tumminello and Suzanne O'Shea from the FDA practice group at Faegre Baker Daniels served as panelists during the Colorado BioScience Association and Faegre Baker Daniels Regulatory Symposium on Wednesday, October 22, 2014. O'Shea and Tumminello discussed the regulation of mobile medical applications in a presentation entitled "Does the FDA Regulate that App?" O'Shea and Tumminello also participated in an interactive discussion regarding the following two case studies presented to the audience:
- Marketing FDA Regulated Products Through Social Media — Social media is a common form of communication for companies. How do FDA-regulated products fit into this information channel? Learn what steps your company can take to comply with the existing FDA guidelines regarding social media as we discuss some of the challenges drug, biologic and device companies face when using this format to promote their products.
- Understanding Your Product's Regulatory Pathway — Are you certain you understand how FDA will evaluate and regulate your new product? How FDA chooses to regulate your product often hinges on terms that are not clearly defined, for example, "intended use" and "chemical action." Our presenters will share real-life experiences involving products that may not be as they appear and will provide suggestions for a company to consider when evaluating which regulatory pathway may apply to their product.