BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

302 related articles for article (PubMed ID: 20082539)

  • 1. Safety-related regulatory actions for orphan drugs in the US and EU: a cohort study.
    Heemstra HE; Giezen TJ; Mantel-Teeuwisse AK; de Vrueh RL; Leufkens HG
    Drug Saf; 2010 Feb; 33(2):127-37. PubMed ID: 20082539
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Safety-related regulatory actions for biologicals approved in the United States and the European Union.
    Giezen TJ; Mantel-Teeuwisse AK; Straus SM; Schellekens H; Leufkens HG; Egberts AC
    JAMA; 2008 Oct; 300(16):1887-96. PubMed ID: 18940975
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Orphan medicinal products in Europe and United States to cover needs of patients with rare diseases: an increased common effort is to be foreseen.
    Giannuzzi V; Conte R; Landi A; Ottomano SA; Bonifazi D; Baiardi P; Bonifazi F; Ceci A
    Orphanet J Rare Dis; 2017 Apr; 12(1):64. PubMed ID: 28372595
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Post-marketing safety-related regulatory actions on first-in-class drugs: A double-cohort study.
    Ikeda J; Kaneko M; Narukawa M
    J Clin Pharm Ther; 2020 Jun; 45(3):496-502. PubMed ID: 31846100
    [TBL] [Abstract][Full Text] [Related]  

  • 5. A decade of safety-related regulatory action in the Netherlands: a retrospective analysis of direct healthcare professional communications from 1999 to 2009.
    Mol PG; Straus SM; Piening S; de Vries JT; de Graeff PA; Haaijer-Ruskamp FM
    Drug Saf; 2010 Jun; 33(6):463-74. PubMed ID: 20486729
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Postmarketing safety of orphan drugs: a longitudinal analysis of the US Food and Drug Administration database between 1999 and 2018.
    Fan M; Chan AYL; Yan VKC; Tong X; Lau LKW; Wan EYF; Tam EYT; Ip P; Lum TY; Wong ICK; Li X
    Orphanet J Rare Dis; 2022 Jan; 17(1):3. PubMed ID: 34983612
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Factors distinguishing important identified risks from important potential risks in orphan and nonorphan drugs: An analysis of safety specifications of Japan and European Union risk management plans.
    Hirota S; Yamaguchi T
    Pharmacoepidemiol Drug Saf; 2018 Nov; 27(11):1231-1238. PubMed ID: 30187590
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Analysis of factors related to the occurrence of important drug-specific postmarketing safety-related regulatory actions: A cohort study focused on first-in-class drugs.
    Ikeda J; Kaneko M; Narukawa M
    Pharmacoepidemiol Drug Saf; 2018 Dec; 27(12):1393-1401. PubMed ID: 30094880
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Impact of safety-related regulatory action on clinical practice: a systematic review.
    Piening S; Haaijer-Ruskamp FM; de Vries JT; van der Elst ME; de Graeff PA; Straus SM; Mol PG
    Drug Saf; 2012 May; 35(5):373-85. PubMed ID: 22480319
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Application of orphan drug designation to cancer treatments (2008-2017): a comprehensive and comparative analysis of the USA and EU.
    Vokinger KN; Kesselheim AS
    BMJ Open; 2019 Oct; 9(10):e028634. PubMed ID: 31601584
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Thirty Years of Orphan Drug Legislation and the Development of Drugs to Treat Rare Seizure Conditions: A Cross Sectional Analysis.
    Döring JH; Lampert A; Hoffmann GF; Ries M
    PLoS One; 2016; 11(8):e0161660. PubMed ID: 27557111
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Effect of safety issues with HIV drugs on the approval process of other drugs in the same class: an analysis of European Public Assessment Reports.
    Arnardottir AH; Haaijer-Ruskamp FM; Straus SM; de Graeff PA; Mol PG
    Drug Saf; 2011 Nov; 34(11):1101-14. PubMed ID: 21981437
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.
    Downing NS; Shah ND; Aminawung JA; Pease AM; Zeitoun JD; Krumholz HM; Ross JS
    JAMA; 2017 May; 317(18):1854-1863. PubMed ID: 28492899
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer.
    Kesselheim AS; Myers JA; Avorn J
    JAMA; 2011 Jun; 305(22):2320-6. PubMed ID: 21642684
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Comparison of regulatory pathways for the approval of advanced therapies in the European Union and the United States.
    Iglesias-Lopez C; Obach M; Vallano A; Agustí A
    Cytotherapy; 2021 Mar; 23(3):261-274. PubMed ID: 33483292
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Timing of new black box warnings and withdrawals for prescription medications.
    Lasser KE; Allen PD; Woolhandler SJ; Himmelstein DU; Wolfe SM; Bor DH
    JAMA; 2002 May; 287(17):2215-20. PubMed ID: 11980521
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Accelerated approval of cancer drugs: improved access to therapeutic breakthroughs or early release of unsafe and ineffective drugs?
    Richey EA; Lyons EA; Nebeker JR; Shankaran V; McKoy JM; Luu TH; Nonzee N; Trifilio S; Sartor O; Benson AB; Carson KR; Edwards BJ; Gilchrist-Scott D; Kuzel TM; Raisch DW; Tallman MS; West DP; Hirschfeld S; Grillo-Lopez AJ; Bennett CL
    J Clin Oncol; 2009 Sep; 27(26):4398-405. PubMed ID: 19636013
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Post-approval safety issues with innovative drugs: a European cohort study.
    Mol PG; Arnardottir AH; Motola D; Vrijlandt PJ; Duijnhoven RG; Haaijer-Ruskamp FM; de Graeff PA; Denig P; Straus SM
    Drug Saf; 2013 Nov; 36(11):1105-15. PubMed ID: 24048690
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Impact of regulatory guidances and drug regulation on risk minimization interventions in drug safety: a systematic review.
    Nkeng L; Cloutier AM; Craig C; Lelorier J; Moride Y
    Drug Saf; 2012 Jul; 35(7):535-46. PubMed ID: 22702638
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Postmarketing Safety-Related Modifications of Drugs Approved by the US Food and Drug Administration Between 1999 and 2014 Without Randomized Controlled Trials.
    Shepshelovich D; Tibau A; Goldvaser H; Ocana A; Seruga B; Amir E
    Mayo Clin Proc; 2019 Jan; 94(1):74-83. PubMed ID: 30611457
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 16.