BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

177 related articles for article (PubMed ID: 17184209)

  • 1. Search for shortcuts on the critical path to market: US FDA perspectives from the diagnostic side.
    Gutman S; Hackett J
    Pharmacogenomics; 2006 Dec; 7(8):1223-7. PubMed ID: 17184209
    [TBL] [Abstract][Full Text] [Related]  

  • 2. [Diagnostic kits in parasitology: which controls?].
    Rossi P
    Parassitologia; 2004 Jun; 46(1-2):145-9. PubMed ID: 15305705
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Food and Drug Administration requirements for testing and approval of new radiopharmaceuticals.
    Harapanhalli RS
    Semin Nucl Med; 2010 Sep; 40(5):364-84. PubMed ID: 20674596
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Molecular biomarkers: a US FDA effort.
    Hong H; Goodsaid F; Shi L; Tong W
    Biomark Med; 2010 Apr; 4(2):215-25. PubMed ID: 20406066
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Biomarker qualification pilot process at the US Food and Drug Administration.
    Goodsaid F; Frueh F
    AAPS J; 2007 Mar; 9(1):E105-8. PubMed ID: 17408233
    [TBL] [Abstract][Full Text] [Related]  

  • 6. The history and contemporary challenges of the US Food and Drug Administration.
    Borchers AT; Hagie F; Keen CL; Gershwin ME
    Clin Ther; 2007 Jan; 29(1):1-16. PubMed ID: 17379043
    [TBL] [Abstract][Full Text] [Related]  

  • 7. FDA marketing claims, and the practitioner.
    Runner S
    J Evid Based Dent Pract; 2006 Mar; 6(1):19-23. PubMed ID: 17138391
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Introduction to the Food and Drug Administration (FDA) regulatory process.
    Hackett JL; Gutman SI
    J Proteome Res; 2005; 4(4):1110-3. PubMed ID: 16083260
    [TBL] [Abstract][Full Text] [Related]  

  • 9. US manufacturing guideline for IVD products.
    Donawa M
    Med Device Technol; 2000 Oct; 11(8):23-4. PubMed ID: 11185183
    [TBL] [Abstract][Full Text] [Related]  

  • 10. The US Food and Drug Administration perspective on cancer biomarker development.
    Gutman S; Kessler LG
    Nat Rev Cancer; 2006 Jul; 6(7):565-71. PubMed ID: 16794639
    [TBL] [Abstract][Full Text] [Related]  

  • 11. What's next after 50 years of psychiatric drug development: an FDA perspective.
    Laughren TP
    J Clin Psychiatry; 2010 Sep; 71(9):1196-204. PubMed ID: 20923624
    [TBL] [Abstract][Full Text] [Related]  

  • 12. A drug's life: the pathway to drug approval.
    Keng MK; Wenzell CM; Sekeres MA
    Clin Adv Hematol Oncol; 2013 Oct; 11(10):646-55. PubMed ID: 24518374
    [TBL] [Abstract][Full Text] [Related]  

  • 13. 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. PubMed ID: 23726388
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Medical devices; classification/reclassification of immunohistochemistry reagents and kits--FDA. Final rule.
    Fed Regist; 1998 Jun; 63(106):30132-42. PubMed ID: 10179865
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Non-clinical Post-Marketing Commitments for newly licenced pharmaceuticals.
    Reeve LM
    Regul Toxicol Pharmacol; 2009 Nov; 55(2):181-7. PubMed ID: 19589365
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Medical devices; exemptions from premarket notification; class II devices--FDA, Final rule.
    Fed Regist; 1998 Nov; 63(212):59222-31. PubMed ID: 10187384
    [TBL] [Abstract][Full Text] [Related]  

  • 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. PubMed ID: 21094692
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Approval of novel biomarkers: FDA's perspective and major requests.
    Scherf U; Becker R; Chan M; Hojvat S
    Scand J Clin Lab Invest Suppl; 2010; 242():96-102. PubMed ID: 20515286
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Adverse effects in women: implications for drug development and regulatory policies.
    Parekh A; Fadiran EO; Uhl K; Throckmorton DC
    Expert Rev Clin Pharmacol; 2011 Jul; 4(4):453-66. PubMed ID: 22114855
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Food and Drug Administration approval process for ophthalmic drugs in the US.
    Lloyd R; Harris J; Wadhwa S; Chambers W
    Curr Opin Ophthalmol; 2008 May; 19(3):190-4. PubMed ID: 18408492
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 9.