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 *

178 related articles for article (PubMed ID: 27580511)

  • 1. Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2016 Aug; 81(169):60169-224. PubMed ID: 27580511
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Foreign establishment registration and listing. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2001 Nov; 66(228):59138-61. PubMed ID: 11776289
    [TBL] [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; 68(238):69009-20. PubMed ID: 14672084
    [TBL] [Abstract][Full Text] [Related]  

  • 4. 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; 73(189):56487-91. PubMed ID: 18985960
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Biological products regulated under Section 351 of the Public Health Service Act; implementation of biologics license; elimination of establishment license and product license; public workshop--FDA. Proposed rule; notice of workshop.
    Fed Regist; 1998 Aug; 63(154):42773-4. PubMed ID: 10182565
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; policies, requirements, and administrative procedures; delay of effective date. Final rule; delay of effective date.
    Food and Drug Administration, HHS
    Fed Regist; 2004 Feb; 69(35):8105-7. PubMed ID: 14997866
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Human cells, tissues, and cellular and tissue-based products; establishment registration and listing. Food and Drug Administration, HHS. Final rule.
    Fed Regist; 2001 Jan; 66(13):5447-69. PubMed ID: 11503777
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Postmarketing safety reports for human drug and biological products; electronic submission requirements. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2014 Jun; 79(111):33072-92. PubMed ID: 24922981
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Amendment to the current good manufacturing practice regulations for finished pharmaceuticals. Direct final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2007 Dec; 72(232):68064-70. PubMed ID: 18064770
    [TBL] [Abstract][Full Text] [Related]  

  • 10. 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]  

  • 11. Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products. Direct final rule.
    Food and Drug Administration, HHS.
    Fed Regist; 2018 Jan; 83(18):3586-9. PubMed ID: 29372981
    [TBL] [Abstract][Full Text] [Related]  

  • 12. 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]  

  • 13. Applications for Food and Drug Administration application approval to market a new drug; revision of postmarketing reporting requirements. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2007 Oct; 72(201):58993-9000. PubMed ID: 17966558
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Medical devices; establishment registration and device listing for manufacturers and distributors of devices--FDA. Direct final rule.
    Fed Regist; 1998 Sep; 63(188):51825-7. PubMed ID: 10185812
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Medical devices; establishment registration and device listing for manufacturers and distributors of devices; companion to direct final rule--FDA. Proposed rule.
    Fed Regist; 1998 Sep; 63(188):51874-5. PubMed ID: 10185813
    [TBL] [Abstract][Full Text] [Related]  

  • 16. 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]  

  • 17. Distribution of blood derivatives by registered blood establishments that qualify as health care entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; delay of applicability date. Final rule; delay of applicability date.
    Food and Drug Administration, HHS
    Fed Regist; 2006 Nov; 71(218):66108-9. PubMed ID: 17099971
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Distribution of certain drug products by registered blood establishments and comprehensive hemophilia diagnostic treatment centers that qualify as health care entities; Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; policies, requirements and administrative procedures. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2008 Oct; 73(197):59496-501. PubMed ID: 18985968
    [TBL] [Abstract][Full Text] [Related]  

  • 19. 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]  

  • 20. Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biologics License Applications. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2015 Jul; 80(127):37971-4. PubMed ID: 26155602
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 9.