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 *

244 related articles for article (PubMed ID: 20818779)

  • 1. NerveCenter: FDA requirements for generic drug applications.
    Ann Neurol; 2010 Sep; 68(3):A11. PubMed ID: 20818779
    [No Abstract]   [Full Text] [Related]  

  • 2. 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]  

  • 3. Lawsuits anticipated on generic biologicals front.
    Fox JL
    Nat Biotechnol; 2003 Jul; 21(7):721-2. PubMed ID: 12833078
    [No Abstract]   [Full Text] [Related]  

  • 4. A precarious balancing act--the role of the FDA as protector of public health and industry wealth.
    McCabe AR
    Suffolk Univ Law Rev; 2003; 36(3):787-819. PubMed ID: 16493844
    [No Abstract]   [Full Text] [Related]  

  • 5. 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]  

  • 6. Greater access to generic drugs. New FDA initiatives to improve drug reviews and reduce legal loopholes.
    Meadows M
    FDA Consum; 2003; 37(5):12-7. PubMed ID: 14666900
    [No Abstract]   [Full Text] [Related]  

  • 7. Sandoz sues FDA over delay in first biogeneric approval.
    Fox JL
    Nat Biotechnol; 2005 Nov; 23(11):1327-8. PubMed ID: 16273046
    [No Abstract]   [Full Text] [Related]  

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

  • 9. Potential pathways for abbreviated approval of generic biologics under existing law and proposed reforms to the law.
    Dinh TQ
    Food Drug Law J; 2007; 62(1):77-137. PubMed ID: 17444027
    [No Abstract]   [Full Text] [Related]  

  • 10. FDA notifications. FDA tentatively approves generic atazanavir.
    AIDS Alert; 2008 Mar; 23(3):32. PubMed ID: 18661639
    [No Abstract]   [Full Text] [Related]  

  • 11. FDA notifications. Tentative approval for generic nevirapine tablets.
    AIDS Alert; 2007 Oct; 22(10):118-9. PubMed ID: 18418905
    [No Abstract]   [Full Text] [Related]  

  • 12. FDA notifications. Tentative approval granted of generic nevirapine.
    AIDS Alert; 2007 Sep; 22(9):104-5. PubMed ID: 18415956
    [No Abstract]   [Full Text] [Related]  

  • 13. FDA notifications. Tentative approval for generic stavudine, oral solution.
    AIDS Alert; 2007 Dec; 22(12):142. PubMed ID: 18415959
    [No Abstract]   [Full Text] [Related]  

  • 14. FDA notifications. Tentative approval for generic lamivudine/zidovudine.
    AIDS Alert; 2007 Oct; 22(10):119-20. PubMed ID: 18416011
    [No Abstract]   [Full Text] [Related]  

  • 15. FDA notifications. Generic lamivudine tentatively approved.
    AIDS Alert; 2008 Mar; 23(3):33. PubMed ID: 18661640
    [No Abstract]   [Full Text] [Related]  

  • 16. FDA notifications. FDA's tentative approval for generic Tenofovir.
    AIDS Alert; 2008 Jan; 23(1):11-2. PubMed ID: 18572475
    [No Abstract]   [Full Text] [Related]  

  • 17. Similar concerns. Safety, costs among the issues to be weighed as FDA grapples with crafting an approval process for generic versions of biological medicines.
    Daly R
    Mod Healthc; 2011 Jul; 41(28):38-40. PubMed ID: 21853593
    [No Abstract]   [Full Text] [Related]  

  • 18. FDA notifications. Generic lopinavir/ritonavir approved by FDA.
    AIDS Alert; 2009 May; 24(5):59. PubMed ID: 19452652
    [No Abstract]   [Full Text] [Related]  

  • 19. SuperGenerics: a better alternative for biogenerics.
    Charles SA
    Drug Discov Today; 2005 Apr; 10(8):533-5. PubMed ID: 15837591
    [No Abstract]   [Full Text] [Related]  

  • 20. Current regulatory and legal considerations for follow-on biologics.
    Kingham RF; Lietzan E
    Clin Pharmacol Ther; 2008 Nov; 84(5):633-5. PubMed ID: 18716615
    [No Abstract]   [Full Text] [Related]  

    [Next]    [New Search]
    of 13.