is being presented by Suzanne O'Shea, Of Counsel, with Baker & Daniels, LLP and airs on Thursday, September 15th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Some view combination products as double the burden, but they also represent an opportunity for creativity and flexibility. And within the complexities of combination products, it is still possible to tailor a regulatory pathway that best meets your specific needs.
This audio conference presentation discusses marketing applications, how many are required and how many would best serve your needs. It also looks at whether the device component of a drug – device combination product can serve as a barrier to generic drug market entry. Our speaker also addresses the issue of cross labeling -- what is it? Is it still a possibility? The presentation explores the flurry of recent guidance documents on companion diagnostics, chemical action, and classifying products as drugs or devices. Do they help or hinder? The presentation provides attendees with a solid understanding of these topics, the possibilities arising from combination product innovations, and the current regulatory environment.
