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Sheraton Silver Spring

Oct 11, 2018 7:30 AM - Oct 12, 2018 4:45 PM

8777 Georgia Ave, Silver Spring, MD 20910

Combination Products Conference

Session 10: Aligning Drug- and Device-led Combination Product Policy

Session Chair(s)

Rachel  Turow, JD, MPH

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


David B. Clissold, JD, MA


David B. Clissold, JD, MA

Hyman Phelps & McNamara, United States


Kate  Cook, JD


Kate Cook, JD

Greenleaf Health, United States

Principal, Regulatory Policy

Kimberly  Trautman, MS


Kimberly Trautman, MS

Trautman International Services, United States

Managing Director

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