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 *

137 related articles for article (PubMed ID: 3207440)

  • 1. Regulating recombinant DNA biologics.
    Crouch ML
    Arzneimittelforschung; 1988 Jul; 38(7):947-9. PubMed ID: 3207440
    [TBL] [Abstract][Full Text] [Related]  

  • 2. No longer "if," but "when": the coming abbreviated approval pathway for follow-on biologics.
    Kelly JJ; David M
    Food Drug Law J; 2009; 64(1):115-48. PubMed ID: 19998743
    [TBL] [Abstract][Full Text] [Related]  

  • 3. The role of the Food and Drug Administration in the regulation of the products of recombinant DNA technology.
    Goldberg M; Miller HI
    Recomb DNA Tech Bull; 1981 Apr; 4(1):15-8. PubMed ID: 7255754
    [TBL] [Abstract][Full Text] [Related]  

  • 4. 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]  

  • 5. 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]  

  • 6. Biological products regulated under Section 351 of the Public Health Services Act; implementation of biologics license; elimination of establishment license and product license; correction--FDA. Proposed rule; correction.
    Fed Regist; 1998 Sep; 63(170):46718. PubMed ID: 10182705
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Well-characterized biotechnology products: evolving to meet the needs of the 21st century.
    Zoon KC
    Dev Biol Stand; 1998; 96():3-8. PubMed ID: 9890510
    [No Abstract]   [Full Text] [Related]  

  • 8. Regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring. Food and Drug Administration, HHS. Final rule.
    Fed Regist; 1999 May; 64(94):26657-70. PubMed ID: 10558516
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Managing the expanded use of biologics across therapeutic areas: an example from b-cell targeted therapies.
    Cohen M; Morrow T; Penna P
    Am J Manag Care; 2006 Mar; 12(2 Suppl):S24-37; quiz S38. PubMed ID: 16551202
    [TBL] [Abstract][Full Text] [Related]  

  • 10. 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]  

  • 11. USDA licensing policy for biologicals produced by R-DNA.
    Espeseth DA; Shibley GP; Joseph PL; van Deusen RA; Whetstone CA
    Dev Biol Stand; 1985; 59():167-73. PubMed ID: 4007275
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Current USDA procedures for licensing biotechnology-derived veterinary biologicals.
    Gay CG
    Dev Biol Stand; 1992; 79():65-74. PubMed ID: 1286767
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Delegations of authority and organization; National Childhood Vaccine Injury Act of 1986--FDA. Final rule.
    Fed Regist; 1993 Apr; 58(61):17105-6. PubMed ID: 10125232
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Canadian regulatory requirements for recombinant fish vaccines.
    Sethi MS; Gifford GA; Samagh BS
    Dev Biol Stand; 1997; 90():347-53. PubMed ID: 9270863
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Food and Drug Administration Modernization Act of 1997; list of documents issued by the Food and Drug Administration that apply to medical devices regulated by the Center for Biologics Evaluation and Research. Food and Drug Administration, HHS. Notice.
    Fed Regist; 1999 Apr; 64(79):20312-3. PubMed ID: 10558481
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Delegations of authority and organization; Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, and Center for Drug Evaluation and Research--FDA. Final rule.
    Fed Regist; 1991 Nov; 56(225):58758-9. PubMed ID: 10115699
    [TBL] [Abstract][Full Text] [Related]  

  • 17. 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]  

  • 18. US biotech prepares to fight generic biologics.
    Reid B
    Nat Biotechnol; 2002 Apr; 20(4):322. PubMed ID: 11923820
    [No Abstract]   [Full Text] [Related]  

  • 19. Quality mammography standards. Department of Health and Human Services (HHS), Public Health Service (PHS), Food and Drug Administration (FDA). Direct final rule.
    Fed Regist; 1999 Jun; 64(116):32404-7. PubMed ID: 10558582
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Biologicals and vaccines: regulatory perspectives.
    Petricciani JC
    Dev Biol Stand; 1986; 63():15-9. PubMed ID: 3743903
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 7.