Wiley Rein to Host FDLI Combination Products Workshop
While the U.S. Food and drug Administration (FDA) has strived to clarify regulatory requirements and coordinate product reviews for combination products among the various centers, it is often difficult to know how a product will be classified and, as a result, what center will be tasked with reviewing its application. Join the Food and Drug Law Institute (FDLI) for the program, "Combination Products Workshop: A Comprehensive Overview" to be held at Wiley Rein’s offices in Washington, DC on December 17, 2015.
At the workshop, Wiley Rein Of Counsel Sonali Gunawardhana will moderate the panel, “Case Studies: A Closer Look at Challenging Examples,” in which panelists will examine three hypothetical combination products and discuss the most effective strategy to steward each through the process of FDA approval.
The fast-paced workshop will also provide attendees with a comprehensive look at how:
- FDA makes its jurisdictional decisions
- To prepare a strategic Request for Designation
- To implement proper manufacturing practices for a combination product
Wiley Rein clients and friends can use code COMBO15 for a 15% discount on the current registration fee. To register or for more information on the event, click here.