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  1.  45
    Blueprint for Transparency at the U.S. Food and Drug Administration: Recommendations to Advance the Development of Safe and Effective Medical Products.Joshua M. Sharfstein, James Dabney Miller, Anna L. Davis, Joseph S. Ross, Margaret E. McCarthy, Brian Smith, Anam Chaudhry, G. Caleb Alexander & Aaron S. Kesselheim - 2017 - Journal of Law, Medicine and Ethics 45 (s2):7-23.
    BackgroundThe U.S. Food and Drug Administration traditionally has kept confidential significant amounts of information relevant to the approval or non-approval of specific drugs, devices, and biologics and about the regulatory status of such medical products in FDA’s pipeline.ObjectiveTo develop practical recommendations for FDA to improve its transparency to the public that FDA could implement by rulemaking or other regulatory processes without further congressional authorization. These recommendations would build on the work of FDA’s Transparency Task Force in 2010.MethodsIn 2016-2017, we convened (...)
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  2.  4
    From COVID Vaccines to HIV Prevention: Pharmaceutical Financing and Distribution for the Public’s Health.Joshua M. Sharfstein, Rena M. Conti & Rebekah E. Gee - 2022 - Journal of Law, Medicine and Ethics 50 (S1):29-31.
    The complexity and inefficiency of the U.S. health care system complicates the distribution of life-saving medical technologies. When the public health is at stake, however, there are alternatives. The proposal for a national PrEP program published in this issue of the Journal applies some of the lessons of the national COVID vaccine campaign to HIV prevention. In doing so, it draws on other examples of public health approaches to the financing of medical technology, from vaccines for children to hepatitis C (...)
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  3.  29
    Introduction.Anna L. Davis, James Dabney Miller, Joshua M. Sharfstein & Aaron S. Kesselheim - 2017 - Journal of Law, Medicine and Ethics 45 (s2):5-6.
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    INTRODUCTION Disrupting the Status Quo: Building Equitable Access to HIV PrEP in the US through Innovative Financing.Jeremiah Johnson, Amy Killelea, Derek T. Dangerfield, Chris Beyrer & Joshua M. Sharfstein - 2022 - Journal of Law, Medicine and Ethics 50 (S1):5-7.
    This special edition ofJLMEcenters on a novel proposal for a national PrEP access program with the potential to break through a failed status quo.
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