BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

152 related articles for article (PubMed ID: 24312157)

  • 1. Bringing New PET drugs to clinical practice - a regulatory perspective.
    Hung JC
    Theranostics; 2013 Nov; 3(11):885-93. PubMed ID: 24312157
    [TBL] [Abstract][Full Text] [Related]  

  • 2. A rational regulatory approach for positron emission tomography imaging probes: from "first in man" to NDA approval and reimbursement.
    Barrio JR; Marcus CS; Hung JC; Keppler JS
    Mol Imaging Biol; 2004; 6(6):361-7. PubMed ID: 15564146
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Food and Drug Administration requirements for testing and approval of new radiopharmaceuticals.
    Harapanhalli RS
    Semin Nucl Med; 2010 Sep; 40(5):364-84. PubMed ID: 20674596
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Regulatory Requirements for PET Drug Production.
    Schwarz SW; Dick D; VanBrocklin HF; Hoffman JM
    J Nucl Med; 2014 Jul; 55(7):1132-7. PubMed ID: 24914057
    [TBL] [Abstract][Full Text] [Related]  

  • 5. FDA's proposed regulations to expand access to investigational drugs for treatment use: the status quo in the guise of reform.
    Rossen BR
    Food Drug Law J; 2009; 64(1):183-223. PubMed ID: 19998746
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Regulation of the compounding of positron emission tomography drugs.
    Hung JC
    Am J Health Syst Pharm; 2001 Jan; 58(2):134-9. PubMed ID: 11202536
    [TBL] [Abstract][Full Text] [Related]  

  • 7. The Academic NDA: Justification, Process, and Lessons Learned.
    Sunderland JJ
    J Nucl Med; 2020 Apr; 61(4):480-487. PubMed ID: 32034112
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Revocation of regulation on positron emission tomography drug products--FDA. Final rule; revocation.
    Fed Regist; 1997 Dec; 62(244):66522. PubMed ID: 10179303
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Proceedings: PET Drugs-A Workshop on Inspections Management and Regulatory Considerations.
    Bunning S; Ignace C; Mattmuller S; Schwarz SW; Scott PJH; VanBrocklin HF; Zigler SS;
    J Nucl Med; 2022 Jul; 63(7):1117-1123. PubMed ID: 35058318
    [TBL] [Abstract][Full Text] [Related]  

  • 10.
    Carlucci G; Ippisch R; Slavik R; Mishoe A; Blecha J; Zhu S
    J Nucl Med; 2021 Feb; 62(2):149-155. PubMed ID: 33443068
    [TBL] [Abstract][Full Text] [Related]  

  • 11. The "treatment IND (investigational new drugs)": public policy considerations.
    Roberts C; Palumbo FB
    J Pharm Mark Manage; 1988; 3(1):41-59. PubMed ID: 10290888
    [TBL] [Abstract][Full Text] [Related]  

  • 12. The radioactive drug research committee: Background and retrospective study of reported research data (1975-2004).
    Suleiman OH; Fejka R; Houn F; Walsh M
    J Nucl Med; 2006 Jul; 47(7):1220-6. PubMed ID: 16818959
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Access to Investigational Drugs: FDA Expanded Access Programs or "Right-to-Try" Legislation?
    Holbein ME; Berglund JP; Weatherwax K; Gerber DE; Adamo JE
    Clin Transl Sci; 2015 Oct; 8(5):526-32. PubMed ID: 25588691
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Federal regulations and reimbursement for PET.
    Keppler JS
    J Nucl Med Technol; 2001 Dec; 29(4):173-9; quiz 180-2. PubMed ID: 11756528
    [TBL] [Abstract][Full Text] [Related]  

  • 15. FDA Approval and Regulation of Pharmaceuticals, 1983-2018.
    Darrow JJ; Avorn J; Kesselheim AS
    JAMA; 2020 Jan; 323(2):164-176. PubMed ID: 31935033
    [TBL] [Abstract][Full Text] [Related]  

  • 16. INDs for PET molecular imaging probes-approach by an academic institution.
    Mosessian S; Duarte-Vogel SM; Stout DB; Roos KP; Lawson GW; Jordan MC; Ogden A; Matter C; Sadeghi S; Mills GQ; Schelbert HR; Radu CG; Czernin J; Couto M; Phelps ME
    Mol Imaging Biol; 2014 Aug; 16(4):441-8. PubMed ID: 24733693
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Current good manufacturing practice for positron emission tomography drugs.
    Food and Drug Administration, HHS
    Fed Regist; 2009 Dec; 74(236):65409-36. PubMed ID: 20169678
    [TBL] [Abstract][Full Text] [Related]  

  • 18. AMCP Partnership Forum: Enabling the Exchange of Clinical and Economic Information Pre-FDA Approval.
    J Manag Care Spec Pharm; 2017 Jan; 23(1):105-112. PubMed ID: 28025919
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Use of 55 PET radiotracers under approval of a Radioactive Drug Research Committee (RDRC).
    Jackson IM; Lee SJ; Sowa AR; Rodnick ME; Bruton L; Clark M; Preshlock S; Rothley J; Rogers VE; Botti LE; Henderson BD; Hockley BG; Torres J; Raffel DM; Brooks AF; Frey KA; Kilbourn MR; Koeppe RA; Shao X; Scott PJH
    EJNMMI Radiopharm Chem; 2020 Nov; 5(1):24. PubMed ID: 33175263
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States.
    Salcher-Konrad M; Naci H; Davis C
    Milbank Q; 2020 Dec; 98(4):1219-1256. PubMed ID: 33021339
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 8.