Using Historical Data to Support Approval of Drug Products for Ophthalmia Neonatorum: Innovative Approach Toward Evidence-Based Medicine

by Sun, Haihao, Temeck, Jean W., McCune, Susan K., Chambers, Wiley A.
Published in JAMA Ophthalmol (2020)

Pediatric Medicine Development: An Overview and Comparison of Regulatory Processes in the European Union and United States

by Penkov, Dobromir, Tomasi, Paolo, Eichler, Irmgard, Murphy, Dianne, Yao, Lynne P., Temeck, Jean
Published in Ther Innov Regul Sci (2017)

Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons Learned

by Sun, Haihao, Temeck, Jean W., Chambers, Wiley, Perkins, Ginger, Bonnel, Renan, Murphy, Dianne
Published in Ther Innov Regul Sci (2017)

A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA from 2007-2013

by Egger, Gunter F., Wharton, Gerold T., Malli, Suzanne, Temeck, Jean, Murphy, M. Dianne, Tomasi, Paolo
Published in Ther Innov Regul Sci (2016)

Duration of Pediatric Clinical Trials Submitted to the US Food and Drug Administration

by Zimmerman, Kanecia O., Smith, P. Brian, McMahon, Ann W., Temeck, Jean, Avant, Debbie, Murphy, Dianne, McCune, Susan
Published in JAMA Pediatr (2019)

Surrogate Endpoints in Pediatric Studies Submitted to the US FDA

by Green, Dionna J., Sun, Haihao, Burnham, Janelle, Liu, Xiaomei I., van den Anker, John, Temeck, Jean, Yao, Lynne, McCune, Susan K., Burckart, Gilbert J.
Published in Clin Pharmacol Ther (2018)