BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

171 related articles for article (PubMed ID: 34170306)

  • 1. Comparison of COVID-19 Vaccine Approvals at the US Food and Drug Administration, European Medicines Agency, and Health Canada.
    Lythgoe MP; Middleton P
    JAMA Netw Open; 2021 Jun; 4(6):e2114531. PubMed ID: 34170306
    [TBL] [Abstract][Full Text] [Related]  

  • 2. A Comparison of EMA and FDA Decisions for New Drug Marketing Applications 2014-2016: Concordance, Discordance, and Why.
    Kashoki M; Hanaizi Z; Yordanova S; Veselý R; Bouygues C; Llinares J; Kweder SL
    Clin Pharmacol Ther; 2020 Jan; 107(1):195-202. PubMed ID: 31306483
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Characteristics of Recent Generic Drug Approvals by the US Food and Drug Administration.
    Jiao K; Gupta R; Fox E; Kesselheim A; Ross JS
    JAMA Netw Open; 2019 Oct; 2(10):e1913029. PubMed ID: 31603482
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe.
    Roberts SA; Allen JD; Sigal EV
    Health Aff (Millwood); 2011 Jul; 30(7):1375-81. PubMed ID: 21680577
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Comparisons of Food and Drug Administration and European Medicines Agency risk management implementation for recent pharmaceutical approvals: report of the International Society for Pharmacoeconomics and outcomes research risk benefit management working group.
    Lis Y; Roberts MH; Kamble S; J Guo J; Raisch DW
    Value Health; 2012 Dec; 15(8):1108-18. PubMed ID: 23244814
    [TBL] [Abstract][Full Text] [Related]  

  • 6. FDA posts record number of drug approvals in 1996.
    Am J Health Syst Pharm; 1997 Mar; 54(5):494, 497-8. PubMed ID: 9066856
    [No Abstract]   [Full Text] [Related]  

  • 7. Has the COVID-19 Crisis Affected the Growth of United States Food and Drug Administration Drug Approvals? The Answer is Not Yet! A Time Series (Forecasting) Study.
    Daizadeh I
    Ther Innov Regul Sci; 2021 May; 55(3):553-557. PubMed ID: 33367967
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration.
    Egilman AC; Kapczynski A; McCarthy ME; Luxkaranayagam AT; Morten CJ; Herder M; Wallach JD; Ross JS
    J Law Med Ethics; 2021; 49(3):456-485. PubMed ID: 34665102
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Muddied messages about FDA.
    Miller HI
    Nat Biotechnol; 2003 Jul; 21(7):732-3. PubMed ID: 12833084
    [No Abstract]   [Full Text] [Related]  

  • 10. FDA authorizes first single-shot COVID-19 vaccine.
    Mullard A
    Nat Rev Drug Discov; 2021 Apr; 20(4):251. PubMed ID: 33707753
    [No Abstract]   [Full Text] [Related]  

  • 11. Being fair to participants in placebo-controlled COVID-19 vaccine trials.
    Dal-Ré R; Orenstein W; Caplan AL
    Nat Med; 2021 Jun; 27(6):938. PubMed ID: 33903751
    [No Abstract]   [Full Text] [Related]  

  • 12. Characteristics of non-randomised studies using comparisons with external controls submitted for regulatory approval in the USA and Europe: a systematic review.
    Goring S; Taylor A; Müller K; Li TJJ; Korol EE; Levy AR; Freemantle N
    BMJ Open; 2019 Feb; 9(2):e024895. PubMed ID: 30819708
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study.
    Hwang TJ; Ross JS; Vokinger KN; Kesselheim AS
    BMJ; 2020 Oct; 371():m3434. PubMed ID: 33028575
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Registering medicines for low-income countries: how suitable are the stringent review procedures of the World Health Organisation, the US Food and Drug Administration and the European Medicines Agency?
    Doua JY; Van Geertruyden JP
    Trop Med Int Health; 2014 Jan; 19(1):23-36. PubMed ID: 24134396
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Accelerating regulation in response to COVID-19.
    Bull World Health Organ; 2020 Aug; 98(8):514-515. PubMed ID: 32773895
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999-2014.
    Hatswell AJ; Baio G; Berlin JA; Irs A; Freemantle N
    BMJ Open; 2016 Jun; 6(6):e011666. PubMed ID: 27363818
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Time required for approval of new drugs in Canada, Australia, Sweden, the United Kingdom and the United States in 1996-1998.
    Rawson NS
    CMAJ; 2000 Feb; 162(4):501-4. PubMed ID: 10701383
    [TBL] [Abstract][Full Text] [Related]  

  • 18. To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016.
    Kühler TC; Bujar M; McAuslane N; Liberti L
    BMJ Open; 2019 Nov; 9(11):e028677. PubMed ID: 31772082
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Assessing tumor-related signs and symptoms to support cancer drug approval.
    Williams G; Pazdur R; Temple R
    J Biopharm Stat; 2004 Feb; 14(1):5-21. PubMed ID: 15027497
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Canadian, European and United States new drug approval times now relatively similar.
    Rawson NSB
    Regul Toxicol Pharmacol; 2018 Jul; 96():121-126. PubMed ID: 29730446
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 9.