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Items: 1 to 20 of 169

1.

An overview of drug development in the United States and current challenges.

Moore SW.

South Med J. 2003 Dec;96(12):1244-55; quiz 1256. Review.

PMID:
14696877
2.

How are drugs approved? Part 1: the evolution of the Food and Drug Administration.

Howland RH.

J Psychosoc Nurs Ment Health Serv. 2008 Jan;46(1):15-9. Review.

PMID:
18251347
3.

How are drugs approved? Part 2: ethical foundations of clinical research.

Howland RH.

J Psychosoc Nurs Ment Health Serv. 2008 Feb;46(2):15-20. Review.

PMID:
18293779
4.

How drugs are developed and approved by the FDA: current process and future directions.

Ciociola AA, Cohen LB, Kulkarni P; FDA-Related Matters Committee of the American College of Gastroenterology.

Am J Gastroenterol. 2014 May;109(5):620-3. doi: 10.1038/ajg.2013.407. Review.

PMID:
24796999
5.

Evaluation of orphan products by the U.S. Food and Drug Administration.

Haffner ME, Kelsey JV.

Int J Technol Assess Health Care. 1992 Fall;8(4):647-57.

PMID:
1464485
6.

U.S. Food and Drug Administration drug approval: slow advances in obstetric care in the United States.

Wing DA, Powers B, Hickok D.

Obstet Gynecol. 2010 Apr;115(4):825-33. doi: 10.1097/AOG.0b013e3181d53843.

PMID:
20308845
7.

The drug approval process and the information it provides.

Myers A, Moore SR.

Drug Intell Clin Pharm. 1987 Oct;21(10):821-6.

PMID:
3322757
9.

Biologics for inflammatory bowel disease: drug approval and monitoring in the United States.

Tremaine WJ.

Gastroenterol Clin North Am. 2006 Dec;35(4):735-41. Review.

PMID:
17129810
10.

Food and Drug Administration requirements for testing and approval of new radiopharmaceuticals.

Harapanhalli RS.

Semin Nucl Med. 2010 Sep;40(5):364-84. doi: 10.1053/j.semnuclmed.2010.05.002. Review.

PMID:
20674596
11.

Regulatory issues in clinical applications of cytokines and growth factors.

Weiss KD, Siegel JP, Gerrard TL.

Prog Growth Factor Res. 1994;5(2):213-22.

PMID:
7919225
13.
14.

Promoting, improving and accelerating the drug development and approval processes.

Graul AI.

Drug News Perspect. 2007 Jan-Feb;20(1):45-55.

PMID:
17332899
15.

Regulatory and scientific issues regarding use of foreign data in support of new drug applications in the United States: an FDA perspective.

Khin NA, Yang P, Hung HM, Maung-U K, Chen YF, Meeker-O'Connell A, Okwesili P, Yasuda SU, Ball LK, Huang SM, O'Neill RT, Temple R.

Clin Pharmacol Ther. 2013 Aug;94(2):230-42. doi: 10.1038/clpt.2013.70. Epub 2013 Apr 3.

PMID:
23588316
16.

The role of the U.S. Food and Drug Administration review process: clinical trial endpoints in oncology.

McKee AE, Farrell AT, Pazdur R, Woodcock J.

Oncologist. 2010;15 Suppl 1:13-8. doi: 10.1634/theoncologist.2010-S1-13.

17.

Characteristics of orphan drug applications that fail to achieve marketing approval in the USA.

Heemstra HE, Leufkens HG, Rodgers RP, Xu K, Voordouw BC, Braun MM.

Drug Discov Today. 2011 Jan;16(1-2):73-80. doi: 10.1016/j.drudis.2010.11.006. Epub 2010 Nov 20. Review.

PMID:
21094692
18.

How are drugs approved? Part 3. The stages of drug development.

Howland RH.

J Psychosoc Nurs Ment Health Serv. 2008 Mar;46(3):17-20. Review.

PMID:
18416270
19.

The FDA and drug safety: a proposal for sweeping changes.

Furberg CD, Levin AA, Gross PA, Shapiro RS, Strom BL.

Arch Intern Med. 2006 Oct 9;166(18):1938-42.

PMID:
17030825
20.

From idea to market: the drug approval process.

Lipsky MS, Sharp LK.

J Am Board Fam Pract. 2001 Sep-Oct;14(5):362-7. Review.

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