BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

667 related articles for article (PubMed ID: 18408492)

  • 21. Quality assurance and the drug development process: an FDA perspective.
    Leonard EM
    Qual Assur; 1994 Jun; 3(2):178-86. PubMed ID: 7804633
    [No Abstract]   [Full Text] [Related]  

  • 22. The Food and Drug Administration's early access and fast-track approval initiatives: how have they worked?
    Shulman SR; Brown JS
    Food Drug Law J; 1995; 50(4):503-31. PubMed ID: 10343017
    [No Abstract]   [Full Text] [Related]  

  • 23. Original research: Intravenous ribavirin--review of the FDA's Emergency Investigational New Drug Database (1997-2008) and literature review.
    Riner A; Chan-Tack KM; Murray JS
    Postgrad Med; 2009 May; 121(3):139-46. PubMed ID: 19491552
    [TBL] [Abstract][Full Text] [Related]  

  • 24. From laboratory to medicine cabinet.
    Caring; 1992 Nov; 11(11):16-20. PubMed ID: 10121248
    [TBL] [Abstract][Full Text] [Related]  

  • 25. Communicating with the FDA: the "third rail" of a new model for drug development.
    Stanski DR; Orloff JJ
    J Clin Pharmacol; 2008 Feb; 48(2):144-5. PubMed ID: 18199890
    [No Abstract]   [Full Text] [Related]  

  • 26. Applications for Food and Drug Administration approval to market a new drug; postmarketing reports; reporting information about authorized generic drugs. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2009 Jul; 74(143):37163-8. PubMed ID: 19655468
    [TBL] [Abstract][Full Text] [Related]  

  • 27. New office and new leader aim to streamline FDA cancer drug review process.
    Twombly R
    J Natl Cancer Inst; 2005 May; 97(10):708-9. PubMed ID: 15900036
    [No Abstract]   [Full Text] [Related]  

  • 28. New drug and antibiotic regulations--FDA. Proposed rule.
    Fed Regist; 1982 Oct; 47(202):46622-66. PubMed ID: 10262075
    [TBL] [Abstract][Full Text] [Related]  

  • 29. Ophthalmic drug development: procedural considerations.
    Novack GD
    J Glaucoma; 1998 Jun; 7(3):202-9. PubMed ID: 9627860
    [No Abstract]   [Full Text] [Related]  

  • 30. Considerations when submitting nanotherapeutics to FDA/CDER for regulatory review.
    Tyner K; Sadrieh N
    Methods Mol Biol; 2011; 697():17-31. PubMed ID: 21116951
    [TBL] [Abstract][Full Text] [Related]  

  • 31. Food and drug administration approval process for dermatology drugs in the United States.
    Boozalis E; Semenov YR; Kwatra SG
    J Dermatolog Treat; 2018 Sep; 29(6):536-538. PubMed ID: 29304565
    [TBL] [Abstract][Full Text] [Related]  

  • 32. Pharmaceutical impurities: regulatory perspective for Abbreviated New Drug Applications.
    Basak AK; Raw AS; Al Hakim AH; Furness S; Samaan NI; Gill DS; Patel HB; Powers RF; Yu L
    Adv Drug Deliv Rev; 2007 Jan; 59(1):64-72. PubMed ID: 17196703
    [TBL] [Abstract][Full Text] [Related]  

  • 33. Economics of new oncology drug development.
    DiMasi JA; Grabowski HG
    J Clin Oncol; 2007 Jan; 25(2):209-16. PubMed ID: 17210942
    [TBL] [Abstract][Full Text] [Related]  

  • 34. Potential pathways for abbreviated approval of generic biologics under existing law and proposed reforms to the law.
    Dinh TQ
    Food Drug Law J; 2007; 62(1):77-137. PubMed ID: 17444027
    [No Abstract]   [Full Text] [Related]  

  • 35. FDA review divisions: performance levels and the impact on drug sponsors.
    Milne CP; Kaitin KI
    Clin Pharmacol Ther; 2012 Mar; 91(3):393-404. PubMed ID: 22336592
    [TBL] [Abstract][Full Text] [Related]  

  • 36. Combination products regulation at the FDA.
    Lauritsen KJ; Nguyen T
    Clin Pharmacol Ther; 2009 May; 85(5):468-70. PubMed ID: 19381151
    [TBL] [Abstract][Full Text] [Related]  

  • 37. Regulatory approvals of pediatric oncology drugs: previous experience and new initiatives.
    Hirschfeld S; Ho PT; Smith M; Pazdur R
    J Clin Oncol; 2003 Mar; 21(6):1066-73. PubMed ID: 12637472
    [TBL] [Abstract][Full Text] [Related]  

  • 38. Utilization of electronic resources in the NDA/BLA regulatory review of bioanalytical data: perspectives from US FDA reviewers.
    Au S; Yu C; Booth B
    Bioanalysis; 2011 Jul; 3(13):1441-5. PubMed ID: 21728769
    [TBL] [Abstract][Full Text] [Related]  

  • 39. Pediatric drug development in anesthesiology: an FDA perspective.
    Schultheis LW; Mathis LL; Roca RA; Simone AF; Hertz SH; Rappaport BA
    Anesth Analg; 2006 Jul; 103(1):49-51. PubMed ID: 16790624
    [No Abstract]   [Full Text] [Related]  

  • 40. FDA drug classification system.
    Sanborn MD; Godwin HN; Pessetto JD
    Am J Hosp Pharm; 1991 Dec; 48(12):2659-62. PubMed ID: 1814217
    [TBL] [Abstract][Full Text] [Related]  

    [Previous]   [Next]    [New Search]
    of 34.