BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

130 related articles for article (PubMed ID: 29988078)

  • 1. Accelerating evidence gathering and approval of precision medicine therapies: the FDA takes aim at rare mutations.
    Issa AM; Thorogood A; Joly Y; Knoppers BM
    Genet Med; 2019 Mar; 21(3):542-544. PubMed ID: 29988078
    [No Abstract]   [Full Text] [Related]  

  • 2. Discussion: The FDA is Unprepared for Personalized Medicine.
    Tabarrok A
    Biostatistics; 2017 Jul; 18(3):403-404. PubMed ID: 28633317
    [No Abstract]   [Full Text] [Related]  

  • 3. Study of pharmacogenomic information in FDA-approved drug labeling to facilitate application of precision medicine.
    Mehta D; Uber R; Ingle T; Li C; Liu Z; Thakkar S; Ning B; Wu L; Yang J; Harris S; Zhou G; Xu J; Tong W; Lesko L; Fang H
    Drug Discov Today; 2020 May; 25(5):813-820. PubMed ID: 32032705
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Toward a Personalized Use of Paclitaxel.
    Russo GL
    Recent Pat Anticancer Drug Discov; 2019; 14(4):296-297. PubMed ID: 31920185
    [No Abstract]   [Full Text] [Related]  

  • 5. Discussion: The role, position, and function of the FDA-The past, present, and future.
    Fleming TR; Demets DL; McShane LM
    Biostatistics; 2017 Jul; 18(3):417-421. PubMed ID: 28633307
    [No Abstract]   [Full Text] [Related]  

  • 6. The FDA Oncology Center of Excellence and precision medicine.
    Goldberg KB; Blumenthal GM; McKee AE; Pazdur R
    Exp Biol Med (Maywood); 2018 Feb; 243(3):308-312. PubMed ID: 29105511
    [TBL] [Abstract][Full Text] [Related]  

  • 7. An appraisal of drug development timelines in the Era of precision oncology.
    Jardim DL; Schwaederle M; Hong DS; Kurzrock R
    Oncotarget; 2016 Aug; 7(33):53037-53046. PubMed ID: 27419632
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Surrogate Endpoints in Pediatric Studies Submitted to the US FDA.
    Green DJ; Sun H; Burnham J; Liu XI; van den Anker J; Temeck J; Yao L; McCune SK; Burckart GJ
    Clin Pharmacol Ther; 2019 Mar; 105(3):555-557. PubMed ID: 30094815
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Regulations, economics hindering adoption of personalized medicine.
    Thompson CA
    Am J Health Syst Pharm; 2011 Mar; 68(5):372-4. PubMed ID: 21330674
    [No Abstract]   [Full Text] [Related]  

  • 10. Carvedilol and the Food and Drug Administration approval process: an introduction.
    Fisher LD; Moyé LA
    Control Clin Trials; 1999 Feb; 20(1):1-15. PubMed ID: 10027497
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Making precision oncology the standard of care.
    The Lancet Oncology
    Lancet Oncol; 2017 Jul; 18(7):835. PubMed ID: 28677559
    [No Abstract]   [Full Text] [Related]  

  • 12. Pharmacogenomic data: FDA voluntary and required submission guidance.
    Salerno RA; Lesko LJ
    Pharmacogenomics; 2004 Jul; 5(5):503-5. PubMed ID: 15212586
    [No Abstract]   [Full Text] [Related]  

  • 13. Ensuring that accelerated approvals benefit patients.
    The Lancet Haematology
    Lancet Haematol; 2021 Sep; 8(9):e613. PubMed ID: 34450093
    [No Abstract]   [Full Text] [Related]  

  • 14. US FDA feels the heat from Congressional hearings.
    Loewenberg S
    Lancet; 2008 May; 371(9624):1565-6. PubMed ID: 18476294
    [No Abstract]   [Full Text] [Related]  

  • 15. The US Food and Drug Administration's use of regular approval for cancer drugs based on single-arm studies: implications for subsequent evidence generation.
    DeLoughery EP; Prasad V
    Ann Oncol; 2018 Mar; 29(3):527-529. PubMed ID: 29346605
    [No Abstract]   [Full Text] [Related]  

  • 16. FDA drug-review, surveillance processes under scrutiny.
    Miller JL
    Am J Health Syst Pharm; 1999 Mar; 56(5):404, 406, 408. PubMed ID: 10096696
    [No Abstract]   [Full Text] [Related]  

  • 17. Evaluating the safety of diabetes drugs: perspective of a Food and Drug Administration insider.
    Misbin RI
    Diabetes Care; 2005 Oct; 28(10):2573-6. PubMed ID: 16186303
    [No Abstract]   [Full Text] [Related]  

  • 18. When it takes two to tango, FDA suggests a new regulatory dance.
    Dolgin E
    Nat Med; 2011 Mar; 17(3):270. PubMed ID: 21383727
    [No Abstract]   [Full Text] [Related]  

  • 19. Perspectives on the Current State of the Biosimilar Regulatory Pathway in the United States.
    Dougherty MK; Zineh I; Christl L
    Clin Pharmacol Ther; 2018 Jan; 103(1):36-38. PubMed ID: 29152721
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Two-stage drug approval would reduce the risks.
    Frantz JA
    Nature; 2005 May; 435(7039):143. PubMed ID: 15889063
    [No Abstract]   [Full Text] [Related]  

    [Next]    [New Search]
    of 7.