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Results: 1 to 20 of 340

1.

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.

PMID:
15494600
[PubMed - indexed for MEDLINE]
Free Article
2.

Accelerated approval of oncology products: the food and drug administration experience.

Johnson JR, Ning YM, Farrell A, Justice R, Keegan P, Pazdur R.

J Natl Cancer Inst. 2011 Apr 20;103(8):636-44. doi: 10.1093/jnci/djr062. Epub 2011 Mar 21. Review.

PMID:
21422403
[PubMed - indexed for MEDLINE]
Free Article
3.

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. Epub 2010 Jan 29. Review. Erratum in: J Natl Cancer Inst. 2010 Apr 21;102(8):578-9.

PMID:
20118413
[PubMed - indexed for MEDLINE]
Free Article
4.

End points and United States Food and Drug Administration approval of oncology drugs.

Johnson JR, Williams G, Pazdur R.

J Clin Oncol. 2003 Apr 1;21(7):1404-11.

PMID:
12663734
[PubMed - indexed for MEDLINE]
Free Article
5.

Oncology drug review process.

Farrell AT, Pazdur R.

J Natl Compr Canc Netw. 2003 Jan;1(1):109-13. Review.

PMID:
19764154
[PubMed - indexed for MEDLINE]
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
[PubMed - indexed for MEDLINE]
7.

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
[PubMed - indexed for MEDLINE]
8.

New drug, antibiotic, and biological drug product regulations; accelerated approval--FDA. Final rule.

[No authors listed]

Fed Regist. 1992 Dec 11;57(239):58942-60.

PMID:
10123232
[PubMed - indexed for MEDLINE]
9.

United States Food and Drug Administration approval summary: bortezomib for the treatment of progressive multiple myeloma after one prior therapy.

Kane RC, Farrell AT, Sridhara R, Pazdur R.

Clin Cancer Res. 2006 May 15;12(10):2955-60.

PMID:
16707588
[PubMed - indexed for MEDLINE]
Free Article
10.

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. Epub 2009 Oct 13. Review.

PMID:
19826112
[PubMed - indexed for MEDLINE]
Free Article
11.

Accelerated approval of cancer drugs: improved access to therapeutic breakthroughs or early release of unsafe and ineffective drugs?

Richey EA, Lyons EA, Nebeker JR, Shankaran V, McKoy JM, Luu TH, Nonzee N, Trifilio S, Sartor O, Benson AB 3rd, Carson KR, Edwards BJ, Gilchrist-Scott D, Kuzel TM, Raisch DW, Tallman MS, West DP, Hirschfeld S, Grillo-Lopez AJ, Bennett CL.

J Clin Oncol. 2009 Sep 10;27(26):4398-405. doi: 10.1200/JCO.2008.21.1961. Epub 2009 Jul 27.

PMID:
19636013
[PubMed - indexed for MEDLINE]
Free PMC Article
12.

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.

PMID:
20237212
[PubMed - indexed for MEDLINE]
Free Article
13.

Accelerated approval seen as triumph and roadblock for cancer drugs.

Susman E.

J Natl Cancer Inst. 2004 Oct 20;96(20):1495-6. No abstract available.

PMID:
15494596
[PubMed - indexed for MEDLINE]
Free Article
14.

Oncology drug development: United States Food and Drug Administration perspective.

Hirschfeld S, Pazdur R.

Crit Rev Oncol Hematol. 2002 May;42(2):137-43. Review.

PMID:
12007971
[PubMed - indexed for MEDLINE]
15.

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
[PubMed - indexed for MEDLINE]
16.

Accelerated approval regulations may need overhaul, panel suggests.

Finkelstein JB.

J Natl Cancer Inst. 2005 Dec 21;97(24):1802-4. No abstract available.

PMID:
16368938
[PubMed - indexed for MEDLINE]
Free Article
17.

From serendipity to design: the evolution of drug development in oncology.

Markman M, Peereboom DM.

Cleve Clin J Med. 1997 Mar;64(3):155-63.

PMID:
9068226
[PubMed - indexed for MEDLINE]
18.

Accelerated approval of oncology drugs: can we do better?

Ellenberg SS.

J Natl Cancer Inst. 2011 Apr 20;103(8):616-7. doi: 10.1093/jnci/djr104. Epub 2011 Mar 21. No abstract available.

PMID:
21422401
[PubMed - indexed for MEDLINE]
Free Article
19.

INGN 201: Ad-p53, Ad5CMV-p53, adenoviral p53, p53 gene therapy--introgen, RPR/INGN 201.

[No authors listed]

Drugs R D. 2007;8(3):176-87. Review.

PMID:
17472413
[PubMed - indexed for MEDLINE]
20.

Trial endpoints for drug approval in oncology: Chemoprevention.

Beitz J.

Urology. 2001 Apr;57(4 Suppl 1):213-5.

PMID:
11295630
[PubMed - indexed for MEDLINE]

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