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PUBMED FOR HANDHELDS

Journal Abstract Search

677 related items for PubMed ID: 18850675

  • 1. Applications for approval to market a new drug; complete response letter; amendments to unapproved applications. Final rule.
    Food and Drug Administration, HHS.
    Fed Regist; 2008 Jul 10; 73(133):39588-611. PubMed ID: 18850675
    [Abstract] [Full Text] [Related]

  • 2. 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
    [Abstract] [Full Text] [Related]

  • 3. Requirements for submission of labeling for human prescription drugs and biologics in electronic format. Final rule.
    Food and Drug Administration, HHS.
    Fed Regist; 2003 Dec 11; 68(238):69009-20. PubMed ID: 14672084
    [Abstract] [Full Text] [Related]

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  • 5. Requirements for submission of bioequivalence data; final rule. Final rule.
    Food and Drug Administration, HHS.
    Fed Regist; 2009 Jan 16; 74(11):2849-62. PubMed ID: 19385107
    [Abstract] [Full Text] [Related]

  • 6. Supplemental applications proposing labeling changes for approved drugs, biologics, and medical devices. Final rule.
    Food and Drug Administration, HHS.
    Fed Regist; 2008 Aug 22; 73(164):49603-10. PubMed ID: 18958946
    [Abstract] [Full Text] [Related]

  • 7. 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]

  • 8. Investigational new drug applications; clinical holds--FDA. Direct final rule.
    Fed Regist; 1998 Dec 14; 63(239):68676-8. PubMed ID: 10187558
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  • 10. Investigational new drugs: export requirements for unapproved new drug products. Final rule.
    Food and Drug Administration, HHS.
    Fed Regist; 2005 Nov 23; 70(225):70720-30. PubMed ID: 16304736
    [Abstract] [Full Text] [Related]

  • 11. FDA's proposed regulations to expand access to investigational drugs for treatment use: the status quo in the guise of reform.
    Rossen BR.
    Food Drug Law J; 2009 Nov 23; 64(1):183-223. PubMed ID: 19998746
    [Abstract] [Full Text] [Related]

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  • 14. Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule.
    Food and Drug Administration, HHS.
    Fed Regist; 2008 Jul 15; 73(136):40453-63. PubMed ID: 18850678
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  • 17. Dissemination of information on unapproved/new uses for marketed drugs, biologics, and devices--FDA. Final rule.
    Fed Regist; 1998 Nov 20; 63(224):64556-88. PubMed ID: 10339052
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  • 19. Investigational new drug application; exception from informed consent; technical amendment--FDA. Final rule.
    Fed Regist; 1997 Jun 16; 62(115):32479. PubMed ID: 10169828
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