BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

313 related articles for article (PubMed ID: 32200551)

  • 1. Expanded Access as a source of real-world data: An overview of FDA and EMA approvals.
    Polak TB; van Rosmalen J; Uyl-de Groot CA
    Br J Clin Pharmacol; 2020 Sep; 86(9):1819-1826. PubMed ID: 32200551
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations.
    Ghadanian M; Schafheutle E
    Ther Innov Regul Sci; 2024 Jan; 58(1):79-113. PubMed ID: 37861859
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Initial and supplementary indication approval of new targeted cancer drugs by the FDA, EMA, Health Canada, and TGA.
    Michaeli DT; Mills M; Michaeli T; Miracolo A; Kanavos P
    Invest New Drugs; 2022 Aug; 40(4):798-809. PubMed ID: 35389145
    [TBL] [Abstract][Full Text] [Related]  

  • 4. 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]  

  • 5. Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019.
    Lythgoe MP; Desai A; Gyawali B; Savage P; Krell J; Warner JL; Khaki AR
    JAMA Netw Open; 2022 Jun; 5(6):e2216183. PubMed ID: 35687337
    [TBL] [Abstract][Full Text] [Related]  

  • 6. 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]  

  • 7. Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017.
    Zhang AD; Puthumana J; Downing NS; Shah ND; Krumholz HM; Ross JS
    JAMA Netw Open; 2020 Apr; 3(4):e203284. PubMed ID: 32315070
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?
    Alqahtani S; Seoane-Vazquez E; Rodriguez-Monguio R; Eguale T
    Pharmacoepidemiol Drug Saf; 2015 Jul; 24(7):709-15. PubMed ID: 26013294
    [TBL] [Abstract][Full Text] [Related]  

  • 9. 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]  

  • 10. 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]  

  • 11. 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]  

  • 12. Patient-reported outcome claims in European and United States orphan drug approvals.
    Jarosławski S; Auquier P; Borissov B; Dussart C; Toumi M
    J Mark Access Health Policy; 2018; 6(1):1542920. PubMed ID: 30425804
    [No Abstract]   [Full Text] [Related]  

  • 13. Use of Real-World Evidence to Support FDA Approval of Oncology Drugs.
    Feinberg BA; Gajra A; Zettler ME; Phillips TD; Phillips EG; Kish JK
    Value Health; 2020 Oct; 23(10):1358-1365. PubMed ID: 33032780
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.
    Downing NS; Aminawung JA; Shah ND; Krumholz HM; Ross JS
    JAMA; 2014 Jan 22-29; 311(4):368-77. PubMed ID: 24449315
    [TBL] [Abstract][Full Text] [Related]  

  • 15. FDA Approval and Regulation of Pharmaceuticals, 1983-2018.
    Darrow JJ; Avorn J; Kesselheim AS
    JAMA; 2020 Jan; 323(2):164-176. PubMed ID: 31935033
    [TBL] [Abstract][Full Text] [Related]  

  • 16. 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]  

  • 17. Regulatory benefit-risk assessment of oncology drugs: A systematic review of FDA and EMA approvals.
    Pinto CA; Balantac Z; Mt-Isa S; Liu X; Bracco OL; Clarke H; Tervonen T
    Drug Discov Today; 2023 Oct; 28(10):103719. PubMed ID: 37467877
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.
    DiMasi JA
    Clin Ther; 2013 Jun; 35(6):808-18. PubMed ID: 23726388
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Characteristics of Single Pivotal Trials Supporting Regulatory Approvals of Novel Non-orphan, Non-oncology Drugs in the European Union and United States from 2012-2016.
    Morant AV; Jagalski V; Vestergaard HT
    Clin Transl Sci; 2019 Jul; 12(4):361-370. PubMed ID: 30681284
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review.
    Wang B; Kesselheim AS
    BMJ; 2015 Sep; 351():h4679. PubMed ID: 26400844
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 16.