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Journal Abstract Search

409 related items for PubMed ID: 11820203

  • 1. 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]

  • 2. The Food and Drug Administration and patent law at a crossroads: the listing of polymorph patents as a barrier to generic drug entry.
    Srivastava D.
    Food Drug Law J; 2004; 59(2):339-54. PubMed ID: 15298015
    [No Abstract] [Full Text] [Related]

  • 3. Drug marketing exclusivity under United States and European Union law.
    Junod V.
    Food Drug Law J; 2004; 59(4):479-518. PubMed ID: 15875347
    [No Abstract] [Full Text] [Related]

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  • 6. 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]

  • 7. Applications for FDA approval to market a dew drug: patent submission and listing requirements and application of 30-month stays on approval of abbreviated new drug applications certifying that a patent claiming a drug is invalid or will not be infringed. Final rule.
    Food and Drug Administration, HHS.
    Fed Regist; 2003 Jun 18; 68(117):36675-712. PubMed ID: 12814136
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  • 9. A precarious balancing act--the role of the FDA as protector of public health and industry wealth.
    McCabe AR.
    Suffolk Univ Law Rev; 2003 Jun 18; 36(3):787-819. PubMed ID: 16493844
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  • 11. Issues in the interpretation of 180-day exclusivity.
    Lietzan E, Korn DE.
    Food Drug Law J; 2007 Jun 18; 62(1):49-75. PubMed ID: 17444026
    [No Abstract] [Full Text] [Related]

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  • 13. Applications for Food and Drug Administration approval to market a new drug; postmarketing reports; reporting information about authorized generic drugs. Final rule.
    Food and Drug Administration, HHS.
    Fed Regist; 2009 Jul 28; 74(143):37163-8. PubMed ID: 19655468
    [Abstract] [Full Text] [Related]

  • 14. Reanalyzing reverse payment settlements: a solution to the patentee's dilemma.
    Wang Z.
    Cornell Law Rev; 2014 Jul 28; 99(5):1227-58. PubMed ID: 25112001
    [No Abstract] [Full Text] [Related]

  • 15. Biogenerics standoff.
    Herrera S.
    Nat Biotechnol; 2004 Nov 28; 22(11):1343-6. PubMed ID: 15529145
    [No Abstract] [Full Text] [Related]

  • 16. FDA's role in administering the Hatch-Waxman Act.
    Malkin BJ.
    Food Drug Law J; 1999 Nov 28; 54(2):211-4. PubMed ID: 11758575
    [No Abstract] [Full Text] [Related]

  • 17. Scientific and legal viability of follow-on protein drugs.
    Dudzinski DM, Kesselheim AS.
    N Engl J Med; 2008 Feb 21; 358(8):843-9. PubMed ID: 18287608
    [No Abstract] [Full Text] [Related]

  • 18. The generic drug approval process.
    Rheinstein PH.
    Am Fam Physician; 1993 Dec 21; 48(8):1357-60. PubMed ID: 8249762
    [No Abstract] [Full Text] [Related]

  • 19. Policy on 180-day marketing exclusivity for drugs marketed under abbreviated new drug applications; clarification--FDA. Clarification.
    Fed Regist; 1997 Nov 28; 62(229):63268-9. PubMed ID: 10177950
    [Abstract] [Full Text] [Related]

  • 20. Implementation of the biosimilar pathway: economic and policy issues.
    Grabowski H, Long G, Mortimer R.
    Seton Hall Law Rev; 2011 Nov 28; 41(2):511-57. PubMed ID: 21739758
    [No Abstract] [Full Text] [Related]

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