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 *

219 related articles for article (PubMed ID: 18691586)

  • 1. FDA revises process for responding to drug applications.
    Lang L
    Gastroenterology; 2008 Sep; 135(3):721. PubMed ID: 18691586
    [No 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; 68(117):36675-712. PubMed ID: 12814136
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Sanofi Pharmaceuticals, Inc., et al.; withdrawal of approval of 21 new drug applications and 62 abbreviated new drug applications--FDA. Notice.
    Fed Regist; 1998 May; 63(91):26191-3. PubMed ID: 10179336
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Digoxin products for oral use; revocation of conditions for marketing. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2002 Jun; 67(123):42992-7. PubMed ID: 12120661
    [TBL] [Abstract][Full Text] [Related]  

  • 5. 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; 74(143):37163-8. PubMed ID: 19655468
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Environmental assessments and findings of no significant impact--FDA. Notice.
    Fed Regist; 1998 May; 63(95):27300-3. PubMed ID: 10179346
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Bioavailability and bioequivalence requirements; abbreviated applications; proposed revisions--FDA. Proposed rule.
    Fed Regist; 1998 Nov; 63(223):64222-8. PubMed ID: 10339051
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Will FDA relinquish the "gold standard" for new drug approval? Redefining "substantial evidence" in the FDA Modernization Act of 1997.
    Kulynych J
    Food Drug Law J; 1999; 54(1):127-49. PubMed ID: 11758555
    [No Abstract]   [Full Text] [Related]  

  • 9. New drug applications; drug master files. Food and Drug Administration, HHS. Final rule.
    Fed Regist; 2000 Jan; 65(8):1776-80. PubMed ID: 11010656
    [TBL] [Abstract][Full Text] [Related]  

  • 10. FDA reform: new Senate bill. Food and Drug Administration.
    James JS
    AIDS Treat News; 1995 Nov; (no 235):7-8. PubMed ID: 11363048
    [TBL] [Abstract][Full Text] [Related]  

  • 11. FDA notifications. FDA grants tentative approval to generic stavudine.
    AIDS Alert; 2006 Feb; 21(2):24. PubMed ID: 16562341
    [No Abstract]   [Full Text] [Related]  

  • 12. FDA regulations. FDA shuts down sale of unregulated HIV drug.
    AIDS Policy Law; 2004 Sep; 19(18):8. PubMed ID: 18680858
    [No Abstract]   [Full Text] [Related]  

  • 13. FDA notifications. FDA grants approval for generic didanosine for oral solution.
    AIDS Alert; 2007 May; 22(5):58-9. PubMed ID: 17577960
    [No Abstract]   [Full Text] [Related]  

  • 14. HIV drugs. FDA new drug approval rate lowest in 10 years.
    AIDS Policy Law; 2007 Jan; 22(2):5. PubMed ID: 17323437
    [No Abstract]   [Full Text] [Related]  

  • 15. FDA notifications. Tentative approval granted for combo antiretroviral drug.
    AIDS Alert; 2007 Oct; 22(10):117-8. PubMed ID: 18416009
    [No Abstract]   [Full Text] [Related]  

  • 16. New drug applications and abbreviated new drug applications; technical amendment. Final rule; technical amendment.
    Food and Drug Administration, HHS
    Fed Regist; 2009 Mar; 74(43):9765-6. PubMed ID: 19418639
    [TBL] [Abstract][Full Text] [Related]  

  • 17. The FDA: a dromedary tale.
    Nat Biotechnol; 1997 Jan; 15(1):1. PubMed ID: 9035089
    [No Abstract]   [Full Text] [Related]  

  • 18. Erythrityl tetranitrate; drug efficacy study implementation; revocation of exemption; opportunity for a hearing--FDA. Notice.
    Fed Regist; 1998 Jun; 63(120):34188-90. PubMed ID: 10180293
    [TBL] [Abstract][Full Text] [Related]  

  • 19. FDA notifications. FDA approval for generic lamivudine/zidovudine.
    AIDS Alert; 2008 Jan; 23(1):12. PubMed ID: 18572476
    [No Abstract]   [Full Text] [Related]  

  • 20. 1992 FDA drug approvals.
    Wynn RL
    Gen Dent; 1993; 41(4):286-7. PubMed ID: 8262339
    [No Abstract]   [Full Text] [Related]  

    [Next]    [New Search]
    of 11.