BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

238 related articles for article (PubMed ID: 16374359)

  • 1. The Food and Drug Administration's Office of Orphan Products Development: incentives, grants, and special designations speed therapies for orphan diseases.
    Haffner ME
    Retina; 2005 Dec; 25(8 Suppl):S89-S90. PubMed ID: 16374359
    [No Abstract]   [Full Text] [Related]  

  • 2. Incentivizing Orphan Product Development: United States Food and Drug Administration Orphan Incentive Programs.
    Le TT
    Adv Exp Med Biol; 2017; 1031():183-196. PubMed ID: 29214572
    [TBL] [Abstract][Full Text] [Related]  

  • 3. The impact of the Orphan Drug Act on the development and advancement of neurological products for rare diseases: a descriptive review.
    Burke KA; Freeman SN; Imoisili MA; Coté TR
    Clin Pharmacol Ther; 2010 Oct; 88(4):449-53. PubMed ID: 20856241
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Navigating through orphan medicinal product regulations in EU and US--similarities and differences.
    Tiwari J
    Regul Toxicol Pharmacol; 2015 Feb; 71(1):63-7. PubMed ID: 25497996
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Rare diseases, orphan drugs and their regulation: questions and misconceptions.
    Tambuyzer E
    Nat Rev Drug Discov; 2010 Dec; 9(12):921-9. PubMed ID: 21060315
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Regulators adopt more orphan drugs.
    Reardon S
    Nature; 2014 Apr; 508(7494):16-7. PubMed ID: 24695293
    [No Abstract]   [Full Text] [Related]  

  • 7. Rare diseases, orphan drugs, and orphaned patients.
    Scheindlin S
    Mol Interv; 2006 Aug; 6(4):186-91. PubMed ID: 16960139
    [No Abstract]   [Full Text] [Related]  

  • 8. Law and research could add up to profitable niche drugs.
    Haefner B
    Nature; 2007 Apr; 446(7138):856. PubMed ID: 17443162
    [No Abstract]   [Full Text] [Related]  

  • 9. Developing treatments for inborn errors: incentives available to the clinician.
    Haffner ME
    Mol Genet Metab; 2004 Apr; 81 Suppl 1():S63-6. PubMed ID: 15050976
    [TBL] [Abstract][Full Text] [Related]  

  • 10. The impact of the Orphan Drug Act on Food and Drug Administration-approved therapies for rare skin diseases and skin-related cancers.
    Karas L; Lu CY; Agrawal PB; Asgari MM
    J Am Acad Dermatol; 2019 Sep; 81(3):867-877. PubMed ID: 31103566
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Orphan drugs and orphan tests in the USA.
    Thoene JG
    Community Genet; 2004; 7(4):169-72. PubMed ID: 15692190
    [No Abstract]   [Full Text] [Related]  

  • 12. Orphanage at the FDA.
    Chen E
    J Cardiovasc Transl Res; 2012 Oct; 5(5):735-6. PubMed ID: 21080134
    [No Abstract]   [Full Text] [Related]  

  • 13. Incentives for orphan drug research and development in the United States.
    Seoane-Vazquez E; Rodriguez-Monguio R; Szeinbach SL; Visaria J
    Orphanet J Rare Dis; 2008 Dec; 3():33. PubMed ID: 19087348
    [TBL] [Abstract][Full Text] [Related]  

  • 14. What the Orphan Drug Act has done lately for children with rare diseases: a 10-year analysis.
    Thorat C; Xu K; Freeman SN; Bonnel RA; Joseph F; Phillips MI; Imoisili MA
    Pediatrics; 2012 Mar; 129(3):516-21. PubMed ID: 22371464
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Ethical imperatives of timely access to orphan drugs: is possible to reconcile economic incentives and patients' health needs?
    Rodriguez-Monguio R; Spargo T; Seoane-Vazquez E
    Orphanet J Rare Dis; 2017 Jan; 12(1):1. PubMed ID: 28057032
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Orphan Drug Act passes quarter-century milestone in fight against rare diseases.
    Lavine G
    Am J Health Syst Pharm; 2008 Jul; 65(13):1205, 1210. PubMed ID: 18574005
    [No Abstract]   [Full Text] [Related]  

  • 17. Regulatory considerations for developing drugs for rare diseases: orphan designations and early phase clinical trials.
    Pariser AR; Xu K; Milto J; Coté TR
    Discov Med; 2011 Apr; 11(59):367-75. PubMed ID: 21524390
    [TBL] [Abstract][Full Text] [Related]  

  • 18. FDA's Office of Orphan Products Development: providing incentives to promote the development of products for rare diseases.
    Patel S; Miller Needleman KI
    J Pharmacokinet Pharmacodyn; 2019 Oct; 46(5):387-393. PubMed ID: 31278433
    [TBL] [Abstract][Full Text] [Related]  

  • 19. The routes to orphan drug designation--our recent experience at the FDA.
    Lev D; Thorat C; Phillips I; Thomas M; Imoisili MA
    Drug Discov Today; 2012 Feb; 17(3-4):97-9. PubMed ID: 22210120
    [No Abstract]   [Full Text] [Related]  

  • 20. A personal perspective of orphan drug development for rare diseases: A golden opportunity or an unsustainable future?
    Oo C; Rusch LM
    J Clin Pharmacol; 2016 Mar; 56(3):257-9. PubMed ID: 26211513
    [No Abstract]   [Full Text] [Related]  

    [Next]    [New Search]
    of 12.