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PUBMED FOR HANDHELDS

Journal Abstract Search


196 related items for PubMed ID: 10177736

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  • 2. New drug applications; drug master files. Food and Drug Administration, HHS. Final rule.
    Fed Regist; 2000 Jan 12; 65(8):1776-80. PubMed ID: 11010656
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  • 3. New drug applications and abbreviated new drug applications; technical amendment. Final rule; technical amendment.
    Food and Drug Administration, HHS.
    Fed Regist; 2009 Mar 06; 74(43):9765-6. PubMed ID: 19418639
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  • 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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  • 8. 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
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  • 9. 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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  • 13. 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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  • 15. Disqualification of a clinical investigator--FDA. Final rule.
    Fed Regist; 1997 Sep 05; 62(172):46875-6. PubMed ID: 10173286
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  • 18. Applications for Food and Drug Administration approval to market a new drug; postmarketing reports; reporting information about authorized generic drugs. Direct final rule.
    Food and Drug Administration, HHS.
    Fed Regist; 2008 Sep 29; 73(189):56487-91. PubMed ID: 18985960
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  • 20. Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.
    Food and Drug Administration, HHS.
    Fed Regist; 2010 Sep 29; 75(188):59935-63. PubMed ID: 20879180
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