These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

398 related articles for article (PubMed ID: 34726771)

  • 41. Use of Real-World Data and Evidence in Drug Development of Medicinal Products Centrally Authorized in Europe in 2018-2019.
    Eskola SM; Leufkens HGM; Bate A; De Bruin ML; Gardarsdottir H
    Clin Pharmacol Ther; 2022 Jan; 111(1):310-320. PubMed ID: 34689334
    [TBL] [Abstract][Full Text] [Related]  

  • 42. How drugs are developed and approved by the FDA: current process and future directions.
    Ciociola AA; Cohen LB; Kulkarni P;
    Am J Gastroenterol; 2014 May; 109(5):620-3. PubMed ID: 24796999
    [TBL] [Abstract][Full Text] [Related]  

  • 43. Predicting Regulatory Product Approvals Using a Proposed Quantitative Version of FDA's Benefit-Risk Framework to Calculate Net-Benefit Score and Benefit-Risk Ratio.
    Sun S; Heske S; Mercadel M; Wimmer J
    Ther Innov Regul Sci; 2021 Jan; 55(1):129-137. PubMed ID: 32643080
    [TBL] [Abstract][Full Text] [Related]  

  • 44. A Retrospective Review of Center for Biologics Evaluation and Research Advisory Committee Meetings in the Context of the FDA's Benefit-Risk Framework.
    Mutanga JN; Nukala U; Rodriguez Messan M; Yogurtcu ON; McCormick Q; Sauna ZE; Whitaker BI; Forshee RA; Yang H
    AAPS J; 2023 Feb; 25(1):24. PubMed ID: 36759415
    [TBL] [Abstract][Full Text] [Related]  

  • 45. New FDA Center May Speed Approval Process.
    Cancer Discov; 2016 Sep; 6(9):OF5. PubMed ID: 27417310
    [TBL] [Abstract][Full Text] [Related]  

  • 46. 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]  

  • 47. Marketing Authorization Applications Made to the European Medicines Agency in 2018-2019: What was the Contribution of Real-World Evidence?
    Flynn R; Plueschke K; Quinten C; Strassmann V; Duijnhoven RG; Gordillo-Marañon M; Rueckbeil M; Cohet C; Kurz X
    Clin Pharmacol Ther; 2022 Jan; 111(1):90-97. PubMed ID: 34689339
    [TBL] [Abstract][Full Text] [Related]  

  • 48. U.S. Food and Drug Administration Reasoning in Approval Decisions When Efficacy Evidence Is Borderline, 2013-2018.
    Janiaud P; Irony T; Russek-Cohen E; Goodman SN
    Ann Intern Med; 2021 Nov; 174(11):1603-1611. PubMed ID: 34543584
    [TBL] [Abstract][Full Text] [Related]  

  • 49. Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States.
    Salcher-Konrad M; Naci H; Davis C
    Milbank Q; 2020 Dec; 98(4):1219-1256. PubMed ID: 33021339
    [TBL] [Abstract][Full Text] [Related]  

  • 50. FDA's proposed regulations to expand access to investigational drugs for treatment use: the status quo in the guise of reform.
    Rossen BR
    Food Drug Law J; 2009; 64(1):183-223. PubMed ID: 19998746
    [TBL] [Abstract][Full Text] [Related]  

  • 51. Contents of US Food and Drug Administration Refuse-to-File Letters for New Drug Applications and Efficacy Supplements and Their Public Disclosure by Applicants.
    Chahal HS; Mukherjee S; Sigelman DW; Temple R
    JAMA Intern Med; 2021 Apr; 181(4):522-529. PubMed ID: 33587091
    [TBL] [Abstract][Full Text] [Related]  

  • 52. FDA's Unimproved Enforcement of Postmarketing Requirements and Commitments: Implications for Providers and Patients.
    Dauner DG; Dauner KN; Peterson ALH
    Res Social Adm Pharm; 2020 Jun; 16(6):844-847. PubMed ID: 31812502
    [TBL] [Abstract][Full Text] [Related]  

  • 53. Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008-2015.
    Zhang AD; Schwartz JL; Ross JS
    Milbank Q; 2019 Sep; 97(3):796-819. PubMed ID: 31304643
    [TBL] [Abstract][Full Text] [Related]  

  • 54. Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019.
    Dhodapkar M; Zhang AD; Puthumana J; Downing NS; Shah ND; Ross JS
    JAMA Netw Open; 2021 Jun; 4(6):e2113224. PubMed ID: 34110392
    [TBL] [Abstract][Full Text] [Related]  

  • 55. Common deficiencies with bioequivalence submissions in abbreviated new drug applications assessed by FDA.
    Liu Q; Davit BM; Cherstniakova SA; Dandamudi S; Walters JF; Lee CH; Raines KW; Ren K; Williamson LN; Conner DP
    AAPS J; 2012 Mar; 14(1):19-22. PubMed ID: 22130775
    [TBL] [Abstract][Full Text] [Related]  

  • 56. Statistical Considerations on the Use of RWD/RWE for Oncology Drug Approvals: Overview and Lessons Learned.
    Ro SK; Zhang W; Jiang Q; Li XN; Liu R; Lu CC; Marchenko O; Sun L; Zhao J
    Ther Innov Regul Sci; 2023 Jul; 57(4):899-910. PubMed ID: 37179264
    [TBL] [Abstract][Full Text] [Related]  

  • 57. Examination of the relationship between oncology drug labeling revision frequency and FDA product categorization.
    Berlin RJ
    Am J Public Health; 2009 Sep; 99(9):1693-8. PubMed ID: 19372515
    [TBL] [Abstract][Full Text] [Related]  

  • 58. Off-label use of medical products in radiation therapy: summary of the report of AAPM Task Group No. 121.
    Thomadsen BR; Heaton HT; Jani SK; Masten JP; Napolitano ME; Ouhib Z; Reft CS; Rivard MJ; Robin TT; Subramanian M; Suleiman OH
    Med Phys; 2010 May; 37(5):2300-11. PubMed ID: 20527564
    [TBL] [Abstract][Full Text] [Related]  

  • 59. The Pharmaceutical Industry in 2017. An Analysis of FDA Drug Approvals from the Perspective of Molecules.
    de la Torre BG; Albericio F
    Molecules; 2018 Feb; 23(3):. PubMed ID: 29495494
    [TBL] [Abstract][Full Text] [Related]  

  • 60. The Use of Real-World Evidence for Regulatory Decisions in China.
    Xu J; Wu W; Zhang X; Ren Y; Yao M; Liu M; Zou K; Wang W; Sun X
    Clin Pharmacol Ther; 2024 Jul; 116(1):82-95. PubMed ID: 38566457
    [TBL] [Abstract][Full Text] [Related]  

    [Previous]   [Next]    [New Search]
    of 20.