The Need for Pediatric Drug Development

Robert M Ward; Daniel K Benjamin Jr; Jonathan M Davis; Richard L Gorman; Ralph Kauffman; Gregory L Kearns; Mary Dianne Murphy; Catherine M T Sherwin

doi:10.1016/j.jpeds.2017.08.011

The Need for Pediatric Drug Development

J Pediatr. 2018 Jan:192:13-21. doi: 10.1016/j.jpeds.2017.08.011. Epub 2017 Sep 21.

Authors

Robert M Ward¹, Daniel K Benjamin Jr², Jonathan M Davis³, Richard L Gorman, Ralph Kauffman, Gregory L Kearns⁴, Mary Dianne Murphy, Catherine M T Sherwin⁵

Affiliations

¹ Department of Pediatrics, University of Utah, School of Medicine, Salt Lake City, UT. Electronic address: [email protected].
² Duke Clinical Research Institute, Duke University, Durham, NC.
³ Neonatal Advisory Committee in the Office of the FDA Commissioner, Silver Spring, MD; Tufts University School of Medicine, Boston, MA.
⁴ Department of Pediatrics, Arkansas Children's Research Institute, University of Arkansas for Medical Sciences, Little Rock, AR.
⁵ Department of Pediatrics, University of Utah, School of Medicine, Salt Lake City, UT.

No abstract available

Keywords: BPCA; Institute for Advanced Clinical Trials for Children; International Neonatal Consortium; PREA; pediatric clinical trials; pediatric pharmacology.

MeSH terms

Child
Clinical Trials as Topic
Drug Development / trends*
Drug Labeling
Guidelines as Topic
Humans
Patient Participation
Pediatrics / trends*
Sulfanilamide / adverse effects
Thalidomide / adverse effects
United States
United States Food and Drug Administration

Substances

Sulfanilamide
Thalidomide

MeSH terms

Substances

Grants and funding