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Journal Abstract Search

1541 related items for PubMed ID: 31935033

  • 1. FDA Approval and Regulation of Pharmaceuticals, 1983-2018.
    Darrow JJ, Avorn J, Kesselheim AS.
    JAMA; 2020 Jan 14; 323(2):164-176. PubMed ID: 31935033
    [Abstract] [Full Text] [Related]

  • 2. Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017.
    Zhang AD, Puthumana J, Downing NS, Shah ND, Krumholz HM, Ross JS.
    JAMA Netw Open; 2020 Apr 01; 3(4):e203284. PubMed ID: 32315070
    [Abstract] [Full Text] [Related]

  • 3. FDA Regulation and Approval of Medical Devices: 1976-2020.
    Darrow JJ, Avorn J, Kesselheim AS.
    JAMA; 2021 Aug 03; 326(5):420-432. PubMed ID: 34342614
    [Abstract] [Full Text] [Related]

  • 4. Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.
    DiMasi JA.
    Clin Ther; 2013 Jun 03; 35(6):808-18. PubMed ID: 23726388
    [Abstract] [Full Text] [Related]

  • 5. Availability of Investigational Medicines Through the US Food and Drug Administration's Expanded Access and Compassionate Use Programs.
    Puthumana J, Miller JE, Kim J, Ross JS.
    JAMA Netw Open; 2018 Jun 01; 1(2):e180283. PubMed ID: 30646072
    [Abstract] [Full Text] [Related]

  • 6. Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy.
    Michaeli DT, Michaeli T, Albers S, Boch T, Michaeli JC.
    Eur J Health Econ; 2024 Aug 01; 25(6):979-997. PubMed ID: 37962724
    [Abstract] [Full Text] [Related]

  • 7. 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 01; 98(4):1219-1256. PubMed ID: 33021339
    [Abstract] [Full Text] [Related]

  • 8. Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?
    Alqahtani S, Seoane-Vazquez E, Rodriguez-Monguio R, Eguale T.
    Pharmacoepidemiol Drug Saf; 2015 Jul 01; 24(7):709-15. PubMed ID: 26013294
    [Abstract] [Full Text] [Related]

  • 9. Examination of risk evaluation and mitigation strategies and drug safety in the US.
    Rodriguez-Monguio R, Spielberger K, Seoane-Vazquez E.
    Res Social Adm Pharm; 2014 Jul 01; 10(1):232-8. PubMed ID: 23611865
    [Abstract] [Full Text] [Related]

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  • 11. Analysis of US Food and Drug Administration new drug and biologic approvals, regulatory pathways, and review times, 1980-2022.
    Seoane-Vazquez E, Rodriguez-Monguio R, Powers JH.
    Sci Rep; 2024 Feb 09; 14(1):3325. PubMed ID: 38336899
    [Abstract] [Full Text] [Related]

  • 12. Coverage of Novel Therapeutic Agents by Medicare Prescription Drug Plans Following FDA Approval.
    Shaw DL, Dhruva SS, Ross JS.
    J Manag Care Spec Pharm; 2018 Dec 09; 24(12):1230-1238. PubMed ID: 30479199
    [Abstract] [Full Text] [Related]

  • 13. Use of US Food and Drug Administration Expedited Drug Development and Review Programs by Orphan and Nonorphan Novel Drugs Approved From 2008 to 2021.
    Monge AN, Sigelman DW, Temple RJ, Chahal HS.
    JAMA Netw Open; 2022 Nov 01; 5(11):e2239336. PubMed ID: 36318210
    [Abstract] [Full Text] [Related]

  • 14.
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  • 15. Expedited Programs for Serious Conditions: An Update on Breakthrough Therapy Designation.
    Kwok M, Foster T, Steinberg M.
    Clin Ther; 2015 Sep 01; 37(9):2104-20. PubMed ID: 26297571
    [Abstract] [Full Text] [Related]

  • 16. The prescription Drug User Fee Act of 1992 and the new drug development process.
    Kaitin KI.
    Am J Ther; 1997 Sep 01; 4(5-6):167-72. PubMed ID: 10423607
    [Abstract] [Full Text] [Related]

  • 17. The US orphan drug programme 1983-1995.
    Shulman SR, Manocchia M.
    Pharmacoeconomics; 1997 Sep 01; 12(3):312-26. PubMed ID: 10170457
    [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 01; 23(1):105-112. PubMed ID: 28025919
    [Abstract] [Full Text] [Related]

  • 19. The history and contemporary challenges of the US Food and Drug Administration.
    Borchers AT, Hagie F, Keen CL, Gershwin ME.
    Clin Ther; 2007 Jan 01; 29(1):1-16. PubMed ID: 17379043
    [Abstract] [Full Text] [Related]

  • 20. Economic Impacts of the Generic Drug User Fee Act Fee Structure.
    Dong K, Boehm G, Zheng Q.
    Value Health; 2017 Jun 01; 20(6):792-798. PubMed ID: 28577697
    [Abstract] [Full Text] [Related]

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