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 *

281 related articles for article (PubMed ID: 1126452)

  • 1. Food and Drug Administration regulations and licensure.
    Barker LF
    Fed Proc; 1975 May; 34(6):1522-4. PubMed ID: 1126452
    [TBL] [Abstract][Full Text] [Related]  

  • 2. 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; 68(238):69009-20. PubMed ID: 14672084
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Operation of a radiopharmacy for a clinical trial.
    Norenberg JP; Petry NA; Schwarz S
    Semin Nucl Med; 2010 Sep; 40(5):347-56. PubMed ID: 20674594
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Current good manufacturing practice regulation and investigational new drugs. Direct final rule.
    Food and Drug Administration. HHS
    Fed Regist; 2006 Jan; 71(10):2458-62. PubMed ID: 16479693
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Application of good manufacturing practice regulations to investigational biologic products.
    Goebel PW
    J Parenter Drug Assoc; 1980; 34(5):348-51. PubMed ID: 6905865
    [No Abstract]   [Full Text] [Related]  

  • 6. 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; 73(136):40453-63. PubMed ID: 18850678
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Requirements on content and format of labeling for human prescription drug and biological products. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2006 Jan; 71(15):3921-97. PubMed ID: 16479698
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients--FDA. Final rule.
    Fed Regist; 1998 Dec; 63(231):66631-72. PubMed ID: 10338880
    [TBL] [Abstract][Full Text] [Related]  

  • 9. WHO Expert Committee on specifications for pharmaceutical preparations.
    World Health Organ Tech Rep Ser; 1996; 863():1-194. PubMed ID: 8952445
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Investigational new drugs: export requirements for unapproved new drug products. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2005 Nov; 70(225):70720-30. PubMed ID: 16304736
    [TBL] [Abstract][Full Text] [Related]  

  • 11. New drug and biological drug products; evidence needed to demonstrate effectiveness of new drugs when human efficacy studies are not ethical or feasible. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2002 May; 67(105):37988-98. PubMed ID: 12049094
    [TBL] [Abstract][Full Text] [Related]  

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

  • 13. Human and veterinary drugs: good manufacturing practices and proposed exemptions for certain OTC products.
    Fed Regist; 1978 Sep; 43(190 Pt 2):45013-89. PubMed ID: 10316700
    [No Abstract]   [Full Text] [Related]  

  • 14. Revisions to the general safety requirements for biological products; companion document to direct final rule--FDA. Proposed rule.
    Fed Regist; 1998 Apr; 63(75):19431-4. PubMed ID: 10178870
    [TBL] [Abstract][Full Text] [Related]  

  • 15. New drug, antibiotic, and biological drug product regulations; accelerated approval--FDA. Final rule.
    Fed Regist; 1992 Dec; 57(239):58942-60. PubMed ID: 10123232
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Revisions to the general safety requirements for biological products--FD. Direct final rule.
    Fed Regist; 1998 Apr; 63(75):19399-403. PubMed ID: 10178869
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Biological products regulated under Section 351 of the Public Health Services Act; implementation of biologics license; elimination of establishment license and product license--FDA. Proposed rule.
    Fed Regist; 1998 Jul; 63(147):40858-71. PubMed ID: 10181717
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Revisions to the requirements applicable to blood, blood components and source plasma. Direct final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2007 Aug; 72(158):45883-88. PubMed ID: 17847577
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Combination products regulation at the FDA.
    Lauritsen KJ; Nguyen T
    Clin Pharmacol Ther; 2009 May; 85(5):468-70. PubMed ID: 19381151
    [TBL] [Abstract][Full Text] [Related]  

  • 20. List of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness. Food and Drug Administration, HHS. Final rule.
    Fed Regist; 1999 Mar; 64(44):10944-7. PubMed ID: 10557618
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 15.