General

WHS General Session: FDA and Wound Healing Prospective

Saturday, April 29, 2023

9:15 AM – 10:15 AM

Moderator(s)

Laura KS Parnell, BS, MS, CWS

President
Precision Consulting
Precision Consulting
Missouri City, TX

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David Margolis, MD, PhD

Professor of Epidemiology and Dermatology
University of Pennsylvania Perelman School of Medicine
Bala Cynwyd, PA

Speaker(s)

K. Dev Verma, MD

Medical Officer
Division of Dermatology and Dentistry, Center for Drug Evaluation and Research, Food and Drug Administration
Silver Spring, MD

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Rosa Sherafat-Kazemzadeh, MD

Lead Physician
US Food and Drug Administration (FDA) /Center for Biologics Research and Evaluation (CBER)
Silver Spring, MD

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Julie Morabito, PhD

Assistant Director, Division of Infection Control and Plastic Surgery Devices, Office of Surgical and Infection Control Devices, Center for Devices and Radiological Health
U.S. Food and Drug Administration
Silver Spring, MD

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Disclosure(s):

Laura KS Parnell, BS, MS, CWS: No financial relationships to disclose

David Margolis, MD, PhD: No relevant disclosure to display

K. Dev Verma, MD: No financial relationships to disclose

Rosa Sherafat-Kazemzadeh, MD: No financial relationships to disclose

Julie Morabito, PhD: No financial relationships to disclose

Speakers from the Food & Drug Administration (FDA) will discuss how potential products are classified and generally proceed through the approval process. Use of data from in vitro, animal, and human in vivo data in the different approval processes will also be discussed. The importance of quality data and key endpoint requirements for wound treatment product regulatory review in regard to the complexity of wound subject health will be touched on.