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 *

139 related articles for article (PubMed ID: 31608600)

  • 21. 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]  

  • 22. Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions.
    Bennett CL; Schoen MW; Hoque S; Witherspoon BJ; Aboulafia DM; Hwang CS; Ray P; Yarnold PR; Chen BK; Schooley B; Taylor MA; Wyatt MD; Hrushesky WJ; Yang YT
    Lancet Oncol; 2020 Dec; 21(12):e575-e588. PubMed ID: 33271114
    [TBL] [Abstract][Full Text] [Related]  

  • 23. What is the European Medicines Agency?
    Bighelli I; Barbui C
    Epidemiol Psychiatr Sci; 2012 Sep; 21(3):245-7. PubMed ID: 22793154
    [TBL] [Abstract][Full Text] [Related]  

  • 24. The requirements for manufacturing highly active or sensitising drugs comparing Good Manufacturing Practices.
    Petrelli F; Caraffa A; Scuri S; Grappasonni I; Magrini E; Cocchini A
    Acta Biomed; 2019 May; 90(2):288-299. PubMed ID: 31125009
    [TBL] [Abstract][Full Text] [Related]  

  • 25. Adaptive designs in clinical trials: from scientific advice to marketing authorisation to the European Medicine Agency.
    Collignon O; Koenig F; Koch A; Hemmings RJ; Pétavy F; Saint-Raymond A; Papaluca-Amati M; Posch M
    Trials; 2018 Nov; 19(1):642. PubMed ID: 30454061
    [TBL] [Abstract][Full Text] [Related]  

  • 26. Flexible and Expedited Regulatory Review Processes for Innovative Medicines and Regenerative Medical Products in the US, the EU, and Japan.
    Nagai S
    Int J Mol Sci; 2019 Aug; 20(15):. PubMed ID: 31382625
    [TBL] [Abstract][Full Text] [Related]  

  • 27. A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.
    Coppens DGM; de Wilde S; Guchelaar HJ; De Bruin ML; Leufkens HGM; Meij P; Hoekman J
    Cytotherapy; 2018 Jun; 20(6):769-778. PubMed ID: 29730080
    [TBL] [Abstract][Full Text] [Related]  

  • 28. Food and Drug Administration requirements for testing and approval of new radiopharmaceuticals.
    Harapanhalli RS
    Semin Nucl Med; 2010 Sep; 40(5):364-84. PubMed ID: 20674596
    [TBL] [Abstract][Full Text] [Related]  

  • 29. [Contact and dialogue between drug companies and the global regulatory authorities throughout research and development phase].
    Kock M; Thomsen MK
    Ugeskr Laeger; 2003 Apr; 165(16):1649-52. PubMed ID: 12756820
    [TBL] [Abstract][Full Text] [Related]  

  • 30. The New Drug Conditional Approval Process in China: Challenges and Opportunities.
    Yao X; Ding J; Liu Y; Li P
    Clin Ther; 2017 May; 39(5):1040-1051. PubMed ID: 28431767
    [TBL] [Abstract][Full Text] [Related]  

  • 31. EMA adopts transparency policy.
    Nat Biotechnol; 2014 Nov; 32(11):1076. PubMed ID: 25380431
    [No Abstract]   [Full Text] [Related]  

  • 32. The value and benefits of the International Conference on Harmonisation to drug regulatory authorities: advancing harmonization for better public health.
    Molzon JA; Giaquinto A; Lindstrom L; Tominaga T; Ward M; Doerr P; Hunt L; Rago L
    Clin Pharmacol Ther; 2011 Apr; 89(4):503-12. PubMed ID: 21326288
    [TBL] [Abstract][Full Text] [Related]  

  • 33. Cell and tissue therapy regulation: worldwide status and harmonization.
    Kellathur SN; Lou HX
    Biologicals; 2012 May; 40(3):222-4. PubMed ID: 22374355
    [TBL] [Abstract][Full Text] [Related]  

  • 34. Bioanalytical method validation: notable points in the 2009 draft EMA Guideline and differences with the 2001 FDA Guidance.
    Smith G
    Bioanalysis; 2010 May; 2(5):929-35. PubMed ID: 21083222
    [No Abstract]   [Full Text] [Related]  

  • 35. What to Know About Medicines With New Active Ingredients Approved in FY 2016 / 2016 in Japan and EU: A Brief Comparison of New Medicines Approved in Japan and the EU in 2016.
    Kondo H; Saint-Raymond A; Yasuda N
    Ther Innov Regul Sci; 2018 Mar; 52(2):214-219. PubMed ID: 29714521
    [TBL] [Abstract][Full Text] [Related]  

  • 36. 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]  

  • 37. 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]  

  • 38. Larger effect sizes in nonrandomized studies are associated with higher rates of EMA licensing approval.
    Djulbegovic B; Glasziou P; Klocksieben FA; Reljic T; VanDenBergh M; Mhaskar R; Ioannidis JPA; Chalmers I
    J Clin Epidemiol; 2018 Jun; 98():24-32. PubMed ID: 29432860
    [TBL] [Abstract][Full Text] [Related]  

  • 39. Why EMA should provide clearer guidance on the authorization of NBCDs in generic and hybrid applications.
    Garattini L; Padula A
    Expert Rev Clin Pharmacol; 2017 Mar; 10(3):243-245. PubMed ID: 27997812
    [No Abstract]   [Full Text] [Related]  

  • 40. Regulatory watch: Impact of scientific advice from the European Medicines Agency.
    Hofer MP; Jakobsson C; Zafiropoulos N; Vamvakas S; Vetter T; Regnstrom J; Hemmings RJ
    Nat Rev Drug Discov; 2015 May; 14(5):302-3. PubMed ID: 25881970
    [No Abstract]   [Full Text] [Related]  

    [Previous]   [Next]    [New Search]
    of 7.