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  1. Article ; Online: Equivalence and regulatory approaches of nonbiological complex drug products across the United States, the European Union, and Turkey.

    Oner, Z Gulsen / Michel, Sarah L J / Polli, James E

    Annals of the New York Academy of Sciences

    2017  Volume 1407, Issue 1, Page(s) 26–38

    Abstract: Regulatory agencies around the world may have different standards and approaches to evaluate and approve drug products and biological products. We describe the U.S. Food and Drug Administration's (FDA) Generic Drug User Fee Act program, as well as their ... ...

    Abstract Regulatory agencies around the world may have different standards and approaches to evaluate and approve drug products and biological products. We describe the U.S. Food and Drug Administration's (FDA) Generic Drug User Fee Act program, as well as their approach to complex products. We discuss regulatory approaches for the development of nonbiological complex drug follow-ons and approval pathways in the United States. We compare FDA policies with other regulatory agencies (i.e., the European Medicines Agency and the Turkish Medicines and Medical Devices Agency). In particular, we describe the policies/pathways across these three agencies to assess equivalence of glatiramer acetate, enoxaparin sodium, and sodium ferric gluconate complex products. We also examine the Turkish market for these selected nonbiological complex drugs.
    Language English
    Publishing date 2017-11
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 211003-9
    ISSN 1749-6632 ; 0077-8923
    ISSN (online) 1749-6632
    ISSN 0077-8923
    DOI 10.1111/nyas.13505
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Outcome-based reimbursement in Central-Eastern Europe and Middle-East.

    Ádám, Ildikó / Callenbach, Marcelien / Németh, Bertalan / Vreman, Rick A / Tollin, Cecilia / Pontén, Johan / Dawoud, Dalia / Elvidge, Jamie / Crabb, Nick / van Waalwijk van Doorn-Khosrovani, Sahar Barjesteh / Pisters-van Roy, Anke / Vincziczki, Áron / Almomani, Emad / Vajagic, Maja / Oner, Z Gulsen / Matni, Mirna / Fürst, Jurij / Kahveci, Rabia / Goettsch, Wim G /
    Kaló, Zoltán

    Frontiers in medicine

    2022  Volume 9, Page(s) 940886

    Abstract: Outcome-based reimbursement models can effectively reduce the financial risk to health care payers in cases when there is important uncertainty or heterogeneity regarding the clinical value of health technologies. Still, health care payers in lower ... ...

    Abstract Outcome-based reimbursement models can effectively reduce the financial risk to health care payers in cases when there is important uncertainty or heterogeneity regarding the clinical value of health technologies. Still, health care payers in lower income countries rely mainly on financial based agreements to manage uncertainties associated with new therapies. We performed a survey, an exploratory literature review and an iterative brainstorming in parallel about potential barriers and solutions to outcome-based agreements in Central and Eastern Europe (CEE) and in the Middle East (ME). A draft list of recommendations deriving from these steps was validated in a follow-up workshop with payer experts from these regions. 20 different barriers were identified in five groups, including transaction costs and administrative burden, measurement issues, information technology and data infrastructure, governance, and perverse policy outcomes. Though implementing outcome-based reimbursement models is challenging, especially in lower income countries, those challenges can be mitigated by conducting pilot agreements and preparing for predictable barriers. Our guidance paper provides an initial step in this process. The generalizability of our recommendations can be improved by monitoring experiences from pilot reimbursement models in CEE and ME countries and continuing the multistakeholder dialogue at national levels.
    Language English
    Publishing date 2022-09-23
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2775999-4
    ISSN 2296-858X
    ISSN 2296-858X
    DOI 10.3389/fmed.2022.940886
    Database MEDical Literature Analysis and Retrieval System OnLINE

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