The FDA PAC (Pediatric Action Committee) is composed of staff from the FDA as well as two national sites at Arkansas Children’s Hospital and the Cleveland Clinic. The study is dedicated to the development of neurologic devices and identifying scientific and medical issues in children undergoing treatment, in order to develop more efficient strategies in evaluating such products regulated by the Agency.

Pediatric Action Committee:

Principal Investigator:

Carlos Peña, PhD, MS
Senior Science Policy Advisor
Office of the Commissioner
Food and Drug Administration
10903 New Hampshire Avenue
WO32-4264
Silver Spring, MD 20993-0002
Tel 301-796-8521
Fax 301-847-8617
E-mail: carlos.pena@fda.hhs.gov

Co-Principal Investigator:

Kristen Bowsher, PhD, Engineer
Office of Device Evaluation
Center for Devices and Radiological Health
E-mail: kristen.bowsher@fda.hhs.gov

Co-Investigators:

John Chelonis, PhD, Staff Fellow
National Center for Toxicological Research
Arkansas Children’s Hospital

Neil Friedman, MBChB, Pediatric Neurologist
Center for Pediatric Neurology
AThe Cleveland Clinic Foundation

Victor Krauthamer, PhD, Scientist
Office of Science and Engineering Laboratories
Center for Devices and Radiological Health

Joy Samuels-Reid, MD, Medical Officer
Office of Device Evaluation
Center for Devices and Radiological Health

Study Staff:

Diane Davies
Center for Pediatric Neurology
The Cleveland Clinic Foundation

Andrea Sutton MAP
National Center for Toxicological Research
Arkansas Children’s Hospital

Chief Information Officer:

Ashish Sarin, MS, Chief Information Officer
Office of the Chief Scientist
Office of the Commissioner
E-mail: ashish.sarin@fda.hhs.gov