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Items: 1 to 20 of 335

1.

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
2.

Exploratory analyses of efficacy data from schizophrenia trials in support of new drug applications submitted to the US Food and Drug Administration.

Khin NA, Chen YF, Yang Y, Yang P, Laughren TP.

J Clin Psychiatry. 2012 Jun;73(6):856-64. doi: 10.4088/JCP.11r07539. Epub 2012 May 15. Review.

PMID:
22687813
4.

FDA's new drug evaluation process: a general overview.

Walters PG.

J Public Health Dent. 1992;52(6):333-7.

PMID:
1432918
5.

Communicating with the FDA: the "third rail" of a new model for drug development.

Stanski DR, Orloff JJ.

J Clin Pharmacol. 2008 Feb;48(2):144-5. doi: 10.1177/0091270007313560. No abstract available.

PMID:
18199890
6.

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
7.

The FDA's new oncology office.

Pazdur R.

Clin Adv Hematol Oncol. 2005 Aug;3(8):612-3. Review. No abstract available.

PMID:
16167044
8.

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

Graul AI.

Drug News Perspect. 2009 Jan-Feb;22(1):30-8. doi: 10.1358/dnp.2009.22.1.1303816.

PMID:
19209297
9.

Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006.

Wang Y, Bhattaram AV, Jadhav PR, Lesko LJ, Madabushi R, Powell JR, Qiu W, Sun H, Yim DS, Zheng JJ, Gobburu JV.

J Clin Pharmacol. 2008 Feb;48(2):146-56. doi: 10.1177/0091270007311111.

PMID:
18199891
10.

The FDA's role in medical device clinical studies of human subjects.

Saviola J.

J Neural Eng. 2005 Mar;2(1):S1-4. Epub 2005 Feb 22. Review.

PMID:
15876645
11.

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
12.

They are from the government and they really are here to help you.

Woosley RL.

J Clin Pharmacol. 2008 Feb;48(2):142-3. doi: 10.1177/0091270007313559. No abstract available.

PMID:
18199889
13.

Assessing tumor-related signs and symptoms to support cancer drug approval.

Williams G, Pazdur R, Temple R.

J Biopharm Stat. 2004 Feb;14(1):5-21. Review.

PMID:
15027497
14.

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

Graul AI.

Drug News Perspect. 2008 Jan-Feb;21(1):36-43. Review.

PMID:
18301808
15.

Characteristics of rare disease marketing applications associated with FDA product approvals 2006-2010.

Pariser AR, Slack DJ, Bauer LJ, Warner CA, Tracy LA.

Drug Discov Today. 2012 Aug;17(15-16):898-904. doi: 10.1016/j.drudis.2012.04.011. Epub 2012 May 5.

PMID:
22564486
16.

Experience with voluntary and required genomic data submissions to the FDA: summary report from track 1 of the third FDA-DIA-PWG-PhRMA-BIO pharmacogenomics workshop.

Frueh FW, Rudman A, Simon K, Gutman S, Reed C, Dorner AJ.

Pharmacogenomics J. 2006 Sep-Oct;6(5):296-300. Epub 2006 Mar 28. No abstract available.

PMID:
16568150
17.

Exploratory analyses of efficacy data from major depressive disorder trials submitted to the US Food and Drug Administration in support of new drug applications.

Khin NA, Chen YF, Yang Y, Yang P, Laughren TP.

J Clin Psychiatry. 2011 Apr;72(4):464-72. doi: 10.4088/JCP.10m06191. Erratum in: J Clin Psychiatry. 2011 Jun;72(6):874.

PMID:
21527123
18.

Reinventing the US Food and Drug Administration.

Fineberg HV.

MedGenMed. 2007 Apr 9;9(2):6. No abstract available.

19.

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
20.

Muddied messages about FDA.

Miller HI.

Nat Biotechnol. 2003 Jul;21(7):732-3. No abstract available.

PMID:
12833084

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