Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012

Abbreviation

JAMA

Publication Date

2014-1-22

Volume

311

Issue

4

Page Numbers

378-84

Pubmed ID

24449316

Full Title

Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012

Authors

Sacks LV, Shamsuddin HH, Yasinskaya YI, Bouri K, Lanthier ML, Sherman RE