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Items: 1 to 20 of 83

1.

Applications for oncologic drugs: a descriptive analysis of the oncologic drugs advisory committee reviews.

Chan JK, Kiet TK, Monk BJ, Young-Lin N, Blansit K, Kapp DS, Amanam I.

Oncologist. 2014 Mar;19(3):299-304. doi: 10.1634/theoncologist.2013-0276.

2.
3.

Oncologic Drugs Advisory Committee Recommendations and Approval of Cancer Drugs by the US Food and Drug Administration.

Tibau A, Ocana A, Anguera G, Seruga B, Templeton AJ, Barnadas A, Amir E.

JAMA Oncol. 2016 Jun 1;2(6):744-50. doi: 10.1001/jamaoncol.2015.6479.

PMID:
26940233
4.

Clinical trial endpoints in ovarian cancer: report of an FDA/ASCO/AACR Public Workshop.

Bast RC, Thigpen JT, Arbuck SG, Basen-Engquist K, Burke LB, Freedman R, Horning SJ, Ozols R, Rustin GJ, Spriggs D, Wenzel LB, Pazdur R.

Gynecol Oncol. 2007 Nov;107(2):173-6.

PMID:
17950384
5.

Rare cancer trial design: lessons from FDA approvals.

Gaddipati H, Liu K, Pariser A, Pazdur R.

Clin Cancer Res. 2012 Oct 1;18(19):5172-8. doi: 10.1158/1078-0432.CCR-12-1135.

6.

Lessons learned from independent central review.

Ford R, Schwartz L, Dancey J, Dodd LE, Eisenhauer EA, Gwyther S, Rubinstein L, Sargent D, Shankar L, Therasse P, Verweij J.

Eur J Cancer. 2009 Jan;45(2):268-74. doi: 10.1016/j.ejca.2008.10.031.

PMID:
19101138
7.

Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.

DiMasi JA.

Clin Ther. 2013 Jun;35(6):808-18. doi: 10.1016/j.clinthera.2013.04.004.

PMID:
23726388
8.

Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer.

Kesselheim AS, Myers JA, Avorn J.

JAMA. 2011 Jun 8;305(22):2320-6. doi: 10.1001/jama.2011.769.

PMID:
21642684
9.

Accelerated approval of oncology products: a decade of experience.

Dagher R, Johnson J, Williams G, Keegan P, Pazdur R.

J Natl Cancer Inst. 2004 Oct 20;96(20):1500-9. Review.

10.

Rituximab: a review of its use in non-Hodgkin's lymphoma and chronic lymphocytic leukaemia.

Plosker GL, Figgitt DP.

Drugs. 2003;63(8):803-43. Review.

PMID:
12662126
11.

Use of multiple endpoints and approval paths depicts a decade of FDA oncology drug approvals.

Shea MB, Roberts SA, Walrath JC, Allen JD, Sigal EV.

Clin Cancer Res. 2013 Jul 15;19(14):3722-31. doi: 10.1158/1078-0432.CCR-13-0316.

12.

Continued challenges with the use of erythropoiesis-stimulating agents in patients with cancer: perspectives and issues on policy-guided health care.

Arbuckle RB, Griffith NL, Iacovelli LM, Johnson PE, Jorgenson JA, Kloth DD, Lucarelli CD, Muller RJ.

Pharmacotherapy. 2008 May;28(5 Pt 2):1S-15S. doi: 10.1592/phco.28.5supp.1S.

PMID:
18447704
13.

Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007.

Sridhara R, Johnson JR, Justice R, Keegan P, Chakravarty A, Pazdur R.

J Natl Cancer Inst. 2010 Feb 24;102(4):230-43. doi: 10.1093/jnci/djp515. Review. Erratum in: J Natl Cancer Inst. 2010 Apr 21;102(8):578-9.

14.

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
15.

FDA advisory committees and the new drug approval process.

Kaitin KI, Melville A, Morris B.

J Clin Pharmacol. 1989 Oct;29(10):886-90.

PMID:
2592579
16.

Food and Drug Administration process for development and approval of drugs and radiopharmaceuticals: treatments in urologic oncology.

Ning YM, Maher VE.

Urol Oncol. 2015 Mar;33(3):137-42. doi: 10.1016/j.urolonc.2014.12.008. Review.

PMID:
25613202
17.

Ultimate fate of oncology drugs approved by the us food and drug administration without a randomized Trial.

Tsimberidou AM, Braiteh F, Stewart DJ, Kurzrock R.

J Clin Oncol. 2009 Dec 20;27(36):6243-50. doi: 10.1200/JCO.2009.23.6018. Review.

PMID:
19826112
18.

Capecitabine: a review.

Walko CM, Lindley C.

Clin Ther. 2005 Jan;27(1):23-44. Review.

PMID:
15763604
19.

Stopping rules employing response rates, time to progression, and early progressive disease for phase II oncology trials.

Goffin JR, Pond GR.

BMC Med Res Methodol. 2011 Dec 12;11:164. doi: 10.1186/1471-2288-11-164.

20.

Quality-of-life end points in cancer clinical trials: the U.S. Food and Drug Administration perspective.

Beitz J, Gnecco C, Justice R.

J Natl Cancer Inst Monogr. 1996;(20):7-9.

PMID:
8750460
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