BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

223 related articles for article (PubMed ID: 33059971)

  • 1. Elements of Regulatory Dissonance: Examining FDA and EMA Product Labeling of New Vaccines (2006-2018).
    Seo Y; Pacifici E
    Vaccine; 2020 Nov; 38(47):7485-7489. PubMed ID: 33059971
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Comparison of novel oncology drugs that received dual approval from the US accelerated approval and EU conditional marketing authorisation pathways, 2006-2021: a cross-sectional study.
    Xie J; Li J; Liu Y; Wang H; Wang Y; Yang Y; Chen Y; Jiang R; Shao R
    BMJ Open; 2023 Jun; 13(6):e069132. PubMed ID: 37286329
    [TBL] [Abstract][Full Text] [Related]  

  • 3. A Review of Patient-Reported Outcomes Labeling for Oncology Drugs Approved by the FDA and the EMA (2012-2016).
    Gnanasakthy A; Barrett A; Evans E; D'Alessio D; Romano CD
    Value Health; 2019 Feb; 22(2):203-209. PubMed ID: 30711065
    [TBL] [Abstract][Full Text] [Related]  

  • 4. 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]  

  • 5. Similarities and differences in the oncology drug approval process between FDA and European Union with emphasis on in vitro companion diagnostics.
    Senderowicz AM; Pfaff O
    Clin Cancer Res; 2014 Mar; 20(6):1445-52. PubMed ID: 24634467
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Comparing cytochrome P450 pharmacogenetic information available on United States drug labels and European Union Summaries of Product Characteristics.
    Reis-Pardal J; Rodrigues A; Rodrigues E; Fernandez-Llimos F
    Pharmacogenomics J; 2017 Dec; 17(6):488-493. PubMed ID: 27241061
    [TBL] [Abstract][Full Text] [Related]  

  • 7. A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs.
    Zeukeng MJ; Seoane-Vazquez E; Bonnabry P
    Eur J Clin Pharmacol; 2018 Jun; 74(6):811-818. PubMed ID: 29470610
    [TBL] [Abstract][Full Text] [Related]  

  • 8. A Comparison of FDA and EMA Pregnancy and Lactation Labeling.
    Kappel D; Sahin L; Yao L; Thor S; Kweder S
    Clin Pharmacol Ther; 2023 Jun; 113(6):1251-1257. PubMed ID: 36645246
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Biosimilars: A consideration of the regulations in the United States and European union.
    Daller J
    Regul Toxicol Pharmacol; 2016 Apr; 76():199-208. PubMed ID: 26732800
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Understanding FDA-Approved Labeling and CDC Recommendations for Use of Vaccines.
    Meissner HC; Farizo K; Pratt D; Pickering LK; Cohn AC
    Pediatrics; 2018 Sep; 142(3):. PubMed ID: 30139807
    [TBL] [Abstract][Full Text] [Related]  

  • 11. 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]  

  • 12. Assessment of PRO label claims granted by the FDA as compared to the EMA (2006-2010).
    DeMuro C; Clark M; Doward L; Evans E; Mordin M; Gnanasakthy A
    Value Health; 2013 Dec; 16(8):1150-5. PubMed ID: 24326168
    [TBL] [Abstract][Full Text] [Related]  

  • 13. EMA and FDA psychiatric drug trial guidelines: assessment of guideline development and trial design recommendations.
    Boesen K; Gøtzsche PC; Ioannidis JPA
    Epidemiol Psychiatr Sci; 2021 Apr; 30():e35. PubMed ID: 33926608
    [TBL] [Abstract][Full Text] [Related]  

  • 14. 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]  

  • 15. 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]  

  • 16. Comparison of the EMA and FDA Guidelines on Ulcerative Colitis Drug Development.
    Reinisch W; Gottlieb K; Colombel JF; Danese S; Panaccione R; Panes J; Peyrin-Biroulet L; Rubin D; Sands BE; Schreiber S; Vermeire S; Mulberg A; Sandborn B
    Clin Gastroenterol Hepatol; 2019 Aug; 17(9):1673-1679.e1. PubMed ID: 31352970
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.
    Yu LX; Baker J; Berlam SC; Boam A; Brandreth EJ; Buhse L; Cosgrove T; Doleski D; Ensor L; Famulare J; Ganapathy M; Grampp G; Hussong D; Iser R; Johnston G; Kesisoglou F; Khan M; Kozlowski S; Lacana E; Lee SL; Miller S; Miksinski SP; Moore CM; Mullin T; Raju GK; Raw A; Rosencrance S; Rosolowsky M; Stinavage P; Thomas H; Wesdyk R; Windisch J; Vaithiyalingam S
    AAPS J; 2015 Jul; 17(4):1011-8. PubMed ID: 25840884
    [TBL] [Abstract][Full Text] [Related]  

  • 18. The Food and Drug Administration reports provided more data but were more difficult to use than the European Medicines Agency reports.
    Schroll JB; Abdel-Sattar M; Bero L
    J Clin Epidemiol; 2015 Jan; 68(1):102-7. PubMed ID: 25150193
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Availability of Investigational Medicines Through the US Food and Drug Administration's Expanded Access and Compassionate Use Programs.
    Puthumana J; Miller JE; Kim J; Ross JS
    JAMA Netw Open; 2018 Jun; 1(2):e180283. PubMed ID: 30646072
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Discrepancies Between US Food and Drug Administration Vaccine Licensure Indications and Advisory Committee on Immunization Practices Recommendations: Provider Knowledge and Attitudes.
    Bell CE; Shane AL; Pickering LK
    Clin Ther; 2018 Aug; 40(8):1308-1319.e16. PubMed ID: 30108001
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 12.