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Session 2: FDA Combination Product Review Process Improvements and Organizational Changes
Session Chair(s)
Rachel Turow, JD, MPH
Managing Counsel, FDA Regulatory
Walmart, Inc., United States
Under the leadership of Commissioner Robert Califf, MD, FDA has embarked on a series of significant process changes aimed at improving combination product regulation. These changes may have the greatest impact on the regulation of combination products since FDA began formally regulating combination products. During this session, FDA will give updates on the internal changes it has made to address issues in the combination products review process, including: establishment of a new Combination Products Policy Council, lean process mapping, a formalized inter-center consult process, and new goals for combination product review under the Prescription Drug User Fee Act.
Speaker(s)
Speaker
Melissa Burns, MS
FDA, United States
Senior Program Manager, Office of Combination Products, OCPP, OC
Speaker
Nina L Hunter, PhD
FDA, United States
Associate Director for Science Policy, Office of Medical Products and Tobacco
Speaker
Cartier Esham, PhD, MSc
Biotechnology Innovation Organization (BIO), United States
Chief Scientific Officer
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