Déjà Vu at the FDA.
作者信息
Sharfstein Joshua
出版信息
Milbank Q. 2017 Jun;95(2):245-248. doi: 10.1111/1468-0009.12252. Epub 2017 Apr 4.
Abstract
摘要
相似文献
1
Déjà Vu at the FDA.
Milbank Q. 2017 Jun;95(2):245-248. doi: 10.1111/1468-0009.12252. Epub 2017 Apr 4.
2
The history and contemporary challenges of the US Food and Drug Administration.
Clin Ther. 2007 Jan;29(1):1-16. doi: 10.1016/j.clinthera.2007.01.006.
3
Drug development and FDA approval, 1938-2013.
N Engl J Med. 2014 Jun 26;370(26):e39. doi: 10.1056/NEJMp1402114.
4
Failing the public health--rofecoxib, Merck, and the FDA.
N Engl J Med. 2004 Oct 21;351(17):1707-9. doi: 10.1056/NEJMp048286. Epub 2004 Oct 6.
5
Rofecoxib, Merck, and the FDA.
N Engl J Med. 2004 Dec 30;351(27):2875-8; author reply 2875-8. doi: 10.1056/NEJM200412303512719.
6
Bioequivalence: the regulatory career of a pharmaceutical concept.
Bull Hist Med. 2011 Spring;85(1):93-131. doi: 10.1353/bhm.2011.0024.
7
Scott Gottlieb and the Credibility of U.S. Therapeutics.
N Engl J Med. 2017 Apr 13;376(15):e30. doi: 10.1056/NEJMp1701738. Epub 2017 Mar 29.
8
Shifting terrain in the regulation of off-label promotion of pharmaceuticals.
N Engl J Med. 2009 Apr 9;360(15):1557-66. doi: 10.1056/NEJMhle0807695.
9
100 years of biologics regulation.
FDA Consum. 2002 Jul-Aug;36(4):8-10.
10
Biopharmaceutical statistics in a pharmaceutical regulated environment: past, present, and future.
J Biopharm Stat. 2001 Nov;11(4):347-72.
本文引用的文献
1
The Koch cancer treatment.
J Hist Med Allied Sci. 1998 Jul;53(3):254-84. doi: 10.1093/jhmas/53.3.254.
2
"Who will bell the cat?" Andrew C. Ivy and Krebiozen.
Bull Hist Med. 1984 Spring;58(1):28-52.
Zotero 插件