In challenging times, biotech, medical device and venture capital firms need to ensure that every aspect of the development plan and regulatory submission is properly addressed when dealing with the FDA in order to avoid long delays and costly mistakes. However, keeping up with the changing regulatory environment can be both challenging, frustrating and time consuming. This session will focus on what companies and venture capitalists alike need to be cognizant of to achieve success in research and development as well as increasing the likelihood of expedited FDA clearance and approvals. Case studies will be provided to highlight both success and failure stories. The panel will also provide an update on the new administration’s plans to reform the FDA approval process.
This topic will cover:
Impact of administration changes on the regulatory process
Hot FDA issues
FDA’s new data initiatives
Pitfalls to avoid with clinical trials and practical suggestions to ensure compliance
Determining regulatory pathways towards product approval, particularly for combination products
Prospecting opportunities to increase product lifecycles
Panelists:
- David L. Rosen, Partner, Foley & Lardner LLP
- Michael A. Swit, Vice President, The Weinberg Group