BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

192 related articles for article (PubMed ID: 32072580)

  • 1. Building a Better Approach for the Benefit of Patients: 10 Pillars to Strengthen Regulatory Review Systems Globally.
    O'Brien J; Lumsden RS; Diehl DH; Macdonald JC
    Ther Innov Regul Sci; 2020 Mar; 54(2):283-292. PubMed ID: 32072580
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Transparency in European Medicines Agency and US Food and Drug Administration Decision Making: Is It Possible to Identify the Rationale for Divergences in Approved Indication From Public Assessment Reports?
    Bujar M; Ferragu S; McAuslane N; Liberti L; Kühler TC
    Clin Ther; 2021 May; 43(5):888-905. PubMed ID: 33883070
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Speeding Access to Vaccines and Medicines in Low- and Middle-Income Countries: A Case for Change and a Framework for Optimized Product Market Authorization.
    Ahonkhai V; Martins SF; Portet A; Lumpkin M; Hartman D
    PLoS One; 2016; 11(11):e0166515. PubMed ID: 27851831
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Regional Differences During the ICH Regulatory Consultation Process Between the EU, US, and Japan.
    Torqui A; Macau AM
    Ther Innov Regul Sci; 2018 Jul; 52(4):438-441. PubMed ID: 29714552
    [TBL] [Abstract][Full Text] [Related]  

  • 5. 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]  

  • 6. 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]  

  • 7. Fifty years of the European medicines regulatory network: reflections for strengthening intra-regional cooperation in the Region of the Americas.
    Allchurch MH; Barbano DB; Pinheiro MH; Lazdin-Helds J
    Rev Panam Salud Publica; 2016 May; 39(5):288-293. PubMed ID: 27706411
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Regulatory advice and drug development--a case study in negotiating with regulators.
    Seldrup J
    Stat Med; 2011 Jun; 30(13):1628-35. PubMed ID: 21365671
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Expanding global access to essential medicines: investment priorities for sustainably strengthening medical product regulatory systems.
    Roth L; Bempong D; Babigumira JB; Banoo S; Cooke E; Jeffreys D; Kasonde L; Leufkens HGM; Lim JCW; Lumpkin M; Mahlangu G; Peeling RW; Rees H; Ndomondo-Sigonda M; Stergachis A; Ward M; Nwokike J
    Global Health; 2018 Nov; 14(1):102. PubMed ID: 30382856
    [TBL] [Abstract][Full Text] [Related]  

  • 10. 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]  

  • 11. From molecule to market access: drug regulatory science as an upcoming discipline.
    Gispen-de Wied CC; Leufkens HGM
    Eur J Pharmacol; 2013 Nov; 719(1-3):9-15. PubMed ID: 23891846
    [TBL] [Abstract][Full Text] [Related]  

  • 12. The European Medicines Agency facilitates access to medicines in low- and middle-income countries.
    Cavaller Bellaubi M; Harvey Allchurch M; Lagalice C; Saint-Raymond A
    Expert Rev Clin Pharmacol; 2020 Mar; 13(3):321-325. PubMed ID: 32053756
    [No Abstract]   [Full Text] [Related]  

  • 13. What makes joint assessment procedures attractive to the innovative industry: successes, challenges, and proposed improvements.
    Miletic N; Adam S; Acquah J; Aziz Z; Joos A; Mwangi JM
    Front Med (Lausanne); 2023; 10():1207954. PubMed ID: 37731723
    [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. Fighting trafficking of falsified and substandard medicinal products in Russia.
    Fayzrakhmanov NF
    Int J Risk Saf Med; 2015; 27 Suppl 1():S37-40. PubMed ID: 26639702
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other?
    Teixeira T; Kweder SL; Saint-Raymond A
    Clin Pharmacol Ther; 2020 Mar; 107(3):507-513. PubMed ID: 31449664
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Sharing regulatory data as tools for strengthening health systems in the Region of the Americas.
    Sousa VD; Ramalho PI; Silveira D
    Rev Panam Salud Publica; 2016 May; 39(5):245-254. PubMed ID: 27706398
    [TBL] [Abstract][Full Text] [Related]  

  • 18. The Global Bioequivalence Harmonization Initiative: Summary report for EUFEPS international conference.
    Chen ML; Blume H; Beuerle G; Davit B; Mehta M; Potthast H; Schug B; Tsang YC; Wedemeyer RS; Weitschies W; Welink J
    Eur J Pharm Sci; 2018 Jan; 111():153-157. PubMed ID: 28964950
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Regional Approaches to Expedited Drug Development and Review: Can Regulatory Harmonization Improve Outcomes?
    Richardson E; Daniel G; Joy DR; Kweder SL; Maloney DM; Raggio MJ; Jarow JP
    Ther Innov Regul Sci; 2018 Nov; 52(6):793-798. PubMed ID: 29714587
    [TBL] [Abstract][Full Text] [Related]  

  • 20.
    ; ; . PubMed ID:
    [No Abstract]   [Full Text] [Related]  

    [Next]    [New Search]
    of 10.