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 *

127 related articles for article (PubMed ID: 31053443)

  • 1. A strategic road map to filing a Biologics License Application for a pluripotent stem cell derived therapeutic product.
    Creasey AA; Stacey G; Bharti K; Sato Y; Lubiniecki A
    Biologicals; 2019 May; 59():68-71. PubMed ID: 31053443
    [No Abstract]   [Full Text] [Related]  

  • 2. Biological products regulated under Section 351 of the Public Health Services Act; implementation of biologics license; elimination of establishment license and product license--FDA. Proposed rule.
    Fed Regist; 1998 Jul; 63(147):40858-71. PubMed ID: 10181717
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Support for the revocation of general safety test regulations in biologics license applications.
    Evans DM; Thorn JM; Arch-Douglas K; Sperry JB; Thompson B; Davis HL; McCluskie MJ
    Biologicals; 2016 May; 44(3):178-81. PubMed ID: 26996102
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Biological products regulated under Section 351 of the Public Health Service Act; implementation of biologics license; elimination of establishment license and product license; public workshop--FDA. Proposed rule; notice of workshop.
    Fed Regist; 1998 Aug; 63(154):42773-4. PubMed ID: 10182565
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Biological products regulated under Section 351 of the Public Health Services Act; implementation of biologics license; elimination of establishment license and product license; correction--FDA. Proposed rule; correction.
    Fed Regist; 1998 Sep; 63(170):46718. PubMed ID: 10182705
    [TBL] [Abstract][Full Text] [Related]  

  • 6. US lawyers investigate trial that secured license for AstraZeneca's antiplatelet drug.
    Cohen D
    BMJ; 2013 Nov; 347():f6727. PubMed ID: 24212110
    [No Abstract]   [Full Text] [Related]  

  • 7. The ability of current biologics law to accommodate emerging technologies.
    Carter MJ
    Food Drug Law J; 1996; 51(3):375-80. PubMed ID: 11797714
    [No Abstract]   [Full Text] [Related]  

  • 8. A consensus conference on complex biologics and low molecular weight heparins.
    Kalodiki E; Fareed J; Tapson VF; Hoppensteadt DA; Sussman I; Carter CA; Parker S; Harenberg J; Hull R; Rao G; Lovinger DF; Ried LD; Kakkar A; Talarico L; Ofuso F; Bussey HI; Fanikos J; Groce JB; Skinner N; Ahluwalia M; Iqbal O; Jackson CM; Jeske WP; Georges M; Ramacciotti E; Tapson VF; Van Thiel D; Wahi R; Walenga J
    Int Angiol; 2010 Apr; 29(2):193-6. PubMed ID: 20351676
    [No Abstract]   [Full Text] [Related]  

  • 9. Revision of the requirements for constituent materials. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2011 Apr; 76(71):20513-8. PubMed ID: 21491807
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Pharmacy compounding of bioidentical hormone replacement therapy (BHRT): a proposed new approach to justify FDA regulation of these prescription drugs.
    Patsner B
    Food Drug Law J; 2008; 63(2):459-91. PubMed ID: 18561473
    [No Abstract]   [Full Text] [Related]  

  • 11. CBER's strategic plan: response from the physician/medical community.
    Parkman PD
    Food Drug Law J; 1996; 51(3):381-2. PubMed ID: 11797715
    [No Abstract]   [Full Text] [Related]  

  • 12. Development of probiotics as biologic drugs.
    Hoffman FA
    Clin Infect Dis; 2008 Feb; 46 Suppl 2():S125-7; discussion S144-51. PubMed ID: 18181717
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Decisions hint that not all biologics are created with equal ease.
    Hutson S
    Nat Med; 2010 Nov; 16(11):1171. PubMed ID: 21052053
    [No Abstract]   [Full Text] [Related]  

  • 14. Food and Drug Administration regulation and evaluation of vaccines.
    Marshall V; Baylor NW
    Pediatrics; 2011 May; 127 Suppl 1():S23-30. PubMed ID: 21502242
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Using a drug-safety tool to prevent competition.
    Sarpatwari A; Avorn J; Kesselheim AS
    N Engl J Med; 2014 Apr; 370(16):1476-8. PubMed ID: 24738666
    [No Abstract]   [Full Text] [Related]  

  • 16. Balancing Safety and Innovation for Cell-Based Regenerative Medicine.
    Marks P; Gottlieb S
    N Engl J Med; 2018 Mar; 378(10):954-959. PubMed ID: 29514023
    [No Abstract]   [Full Text] [Related]  

  • 17. Utilization of electronic resources in the NDA/BLA regulatory review of bioanalytical data: perspectives from US FDA reviewers.
    Au S; Yu C; Booth B
    Bioanalysis; 2011 Jul; 3(13):1441-5. PubMed ID: 21728769
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Reflections on historical, scientific, and legal issues relevant to designing approval pathways for generic versions of recombinant protein-based therapeutics and monoclonal antibodies.
    Dudzinski DM
    Food Drug Law J; 2005; 60(2):143-260. PubMed ID: 16094771
    [No Abstract]   [Full Text] [Related]  

  • 19. Flight 483 now boarding.
    Czap A
    Altern Med Rev; 2010 Sep; 15(3):183-5. PubMed ID: 21155619
    [No Abstract]   [Full Text] [Related]  

  • 20. US biosimilar pathway unlikely to be used: developers will opt for a traditional BLA filing.
    Wiatr C
    BioDrugs; 2011 Feb; 25(1):63-7. PubMed ID: 21222498
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 7.