Regenerative medicine and related cell/tissue therapies offer significant promise in improving the quality of life of patients suffering from a wide variety of health concerns. In direct response to life sciences companies allocating significant resources to regenerative medicines, the FDA has released no less than four draft guidances related to the development and regulation of these and related therapies in 2015 alone. Additionally, the FDA is holding a public hearing at the National Institutes of Health Campus in September 2016 to obtain comments on the four 2015 guidance documents. The good news is a framework is taking shape. The bad news is most of us are left with more questions than answers.
To help you navigate the confusing waters of bringing regenerative medicines to market, LSTI has partnered with the law firm of Fuerst Ittleman David & Joseph, PL to offer a webinar that will help you make sense of the pending regulatory landscape so you can be prepared for any eventuality.
If you and your colleagues are interested in understanding the guidances and getting a glimpse into your future regulatory obligations, then join us for this 90-minute interactive presentation where you will learn:
- An introduction to FDA’s regulation of regenerative medicine
- What regulatory risks exist under FDA’s current regulatory framework
- The viable FDA pathways to bring regenerative medicine products to market in the United States
- An overview of international regenerative medicine programs and medical tourism
- What the future holds: What to expect from FDA and Capitol Hill in the coming months and years, and how that will shape your development plan
Our interactive session will provide you with ample opportunity to ask our global experts detailed questions related to your efforts.