Standardizing Safety Assessment and Reporting for Neonatal Clinical Trials

Affiliations

• ¹ The Floating Hospital for Children at Tufts Medical Center and the Tufts Clinical and Translational Science Institute, Boston, MA. Electronic address: jdavis@tuftsmedicalcenter.org.
• ² US Food and Drug Administration, Office of Pediatric Therapeutics, Silver Spring, MD.
• ³ Health Canada, Ottawa, Ontario, Canada.
• ⁴ Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
• ⁵ Chiesi Farmaceutici SpA, Parma, Italy.
• ⁶ Takeda Pharmaceutical Company Limited, Zug, Switzerland.
• ⁷ Eli Lilly and Co, Indianapolis, IN.
• ⁸ Independent Consultant Pharmaceutical Physician, Durham, NC.
• ⁹ Paidion Research Inc, Durham, NC.
• ¹⁰ St. Marianna University, Kawasaki, Japan.
• ¹¹ National Center for Child Health and Development, Tokyo, Japan.
• ¹² Department of Development and Regeneration, KU Leuven, Leuven, Belgium.
• ¹³ Department of Development and Regeneration, KU Leuven, Leuven, Belgium; Department of Pediatrics, Division of Neonatology, Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.
• ¹⁴ US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD.
• ¹⁵ Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom.
• ¹⁶ Novartis Pharmaceuticals, East Hanover, NJ.
• ¹⁷ Critical Path Institute, Tucson, AZ.