BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

148 related articles for article (PubMed ID: 15940853)

  • 1. Takings issues in the approval of generic biologics.
    Yoo JC
    Food Drug Law J; 2005; 60(1):33-43. PubMed ID: 15940853
    [No Abstract]   [Full Text] [Related]  

  • 2. Generic drugs: the stalling game.
    Consum Rep; 2001 Jul; 66(7):36-40. PubMed ID: 11725791
    [TBL] [Abstract][Full Text] [Related]  

  • 3. GATT implementation and generic drug approval.
    Safir PO; Lassman SM
    Food Drug Law J; 1996; 51(2):295-302. PubMed ID: 11820203
    [No Abstract]   [Full Text] [Related]  

  • 4. The generic drug approval process.
    Rheinstein PH
    Am Fam Physician; 1993 Dec; 48(8):1357-60. PubMed ID: 8249762
    [No Abstract]   [Full Text] [Related]  

  • 5. 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]  

  • 6. Draft guidance for industry on developing medical imaging drugs and biologics; availability--FDA. Availability of guidance.
    Fed Regist; 1998 Oct; 63(198):55067-9. PubMed ID: 10185833
    [TBL] [Abstract][Full Text] [Related]  

  • 7. United States Food and Drug Administration requirements for approval of generic drug products.
    Meyer MC
    J Clin Psychiatry; 2001; 62 Suppl 5():4-9; discussion 23-4. PubMed ID: 11305846
    [TBL] [Abstract][Full Text] [Related]  

  • 8. The Food and Drug Administration's early access and fast-track approval initiatives: how have they worked?
    Shulman SR; Brown JS
    Food Drug Law J; 1995; 50(4):503-31. PubMed ID: 10343017
    [No Abstract]   [Full Text] [Related]  

  • 9. Recent developments help the defense of drug companies in 10b-5 cases.
    Salpeter AN; Hutchins H
    Food Drug Law J; 1996; 51(3):345-53. PubMed ID: 11797711
    [No Abstract]   [Full Text] [Related]  

  • 10. The FDA and "privatization"--the drug approval process.
    Rutherford EM
    Food Drug Law J; 1995; 50 Spec():203-25. PubMed ID: 10343044
    [No Abstract]   [Full Text] [Related]  

  • 11. Generic substitution: issues for problematic drugs.
    Henderson JD; Esham RH
    South Med J; 2001 Jan; 94(1):16-21. PubMed ID: 11213935
    [TBL] [Abstract][Full Text] [Related]  

  • 12. 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]  

  • 13. Initial responses to recommendations of the Blue Ribbon Committee on Generic Medicines.
    Heller WM
    Am J Hosp Pharm; 1993 Feb; 50(2):318-22. PubMed ID: 8480792
    [No Abstract]   [Full Text] [Related]  

  • 14. Current issues in the pioneer versus generic drug wars.
    Safir PO
    Food Drug Law J; 1995; 50(2):335-9. PubMed ID: 10343002
    [No Abstract]   [Full Text] [Related]  

  • 15. Generic drug product equivalence: current status.
    Meyer MC
    Am J Manag Care; 1998 Aug; 4(8):1183-9; quiz 1190-2. PubMed ID: 10182892
    [TBL] [Abstract][Full Text] [Related]  

  • 16. FDA's role in making exclusivity determinations.
    Dickinson EH
    Food Drug Law J; 1999; 54(2):195-203. PubMed ID: 11758573
    [No Abstract]   [Full Text] [Related]  

  • 17. FDA's role in administering the Hatch-Waxman Act.
    Malkin BJ
    Food Drug Law J; 1999; 54(2):211-4. PubMed ID: 11758575
    [No Abstract]   [Full Text] [Related]  

  • 18. Entry decisions in the generic pharmaceutical industry.
    Morton FM
    Rand J Econ; 1999; 30(3):421-40. PubMed ID: 10558596
    [TBL] [Abstract][Full Text] [Related]  

  • 19. CBER status on reform initiatives: industry reactions and comments.
    Page M
    Food Drug Law J; 1997; 52(2):193-6. PubMed ID: 10557559
    [No Abstract]   [Full Text] [Related]  

  • 20. Multisource drugs: implications and concerns in the geriatric population.
    Gerbino PP; Joseph AS
    Hosp Pharm; 1993 Feb; 28(2):96-8, 101-2. PubMed ID: 10125706
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 8.