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Session 10: Aligning Drug- and Device-led Combination Product Policy
Session Chair(s)
Rachel Turow, JD, MPH
Managing Counsel, FDA Regulatory
Walmart, Inc., United States
As FDA works through many of the policy questions that affect all combination product sponsors, the specific issues affecting drugs and devices diverge. This panel will discuss the challenges OCP faces in creating cohesive policy in an area with stakeholders that have very different priorities. We will also discuss how this affects efforts at FDA to align policy across centers and combination product types.
Learning Objective : Upon completion of this session, participants should be able to:- Describe the top issues affecting device-led combination products
- Describe the top issues affecting drug-led combination products
- Understand the challenges FDA faces in meeting divergent stakeholder needs
Speaker(s)
Panelist
David B. Clissold, JD, MA
Hyman Phelps & McNamara, United States
Director
Panelist
Kate Cook, JD
Greenleaf Health, United States
Principal, Regulatory Policy
Panelist
Kimberly Trautman, MS
Trautman International Services, United States
Managing Director