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Interchangeable Insulins — New Pathways for Safe, Effective, Affordable Diabetes Therapy

List of authors.
  • Mariana P. Socal, M.D., Ph.D.,
  • and Jeremy A. Greene, M.D., Ph.D.

Draft FDA guidance would reduce barriers to marketing high-quality generic insulin in the United States by declaring that the evidence necessary for proving an insulin product “highly similar” to an existing product is sufficient for designating it as interchangeable.

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Funding and Disclosures

Disclosure forms provided by the authors are available at NEJM.org.

Author Affiliations

From the Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health (M.P.S.), and the Department of History of Medicine and the Center for Medical Humanities and Social Medicine, Johns Hopkins University School of Medicine (J.A.G.) — both in Baltimore.

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