The US Food and Drug Administration's Model-Informed Drug Development Paired Meeting Pilot Program: Early Experience and Impact

Clin Pharmacol Ther. 2019 Jul;106(1):74-78. doi: 10.1002/cpt.1457. Epub 2019 May 13.

Authors

Rajanikanth Madabushi¹, Jessica M Benjamin¹, Renmeet Grewal¹, Michael A Pacanowski¹, David G Strauss¹, Yaning Wang¹, Hao Zhu¹, Issam Zineh¹

Affiliation

¹ 1Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland, USA.

PMID: 31081932
DOI: 10.1002/cpt.1457

No abstract available

MeSH terms

Drug Approval / organization & administration
Drug Development / organization & administration*
Humans
Interdisciplinary Communication
Product Surveillance, Postmarketing*
United States
United States Food and Drug Administration / organization & administration*