Drug Safety Project

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Research & Analysis

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  • Drug Shortages

    National drug shortages, defined by the U.S. Food and Drug Administration (FDA) as a period of time when the demand or projected demand for a drug within the United States exceeds the supply of the drug, remain a complex and multilayered issue in the U.S. health care delivery system. Read More

  • How Market Forces Contribute to Drug Shortages

    When lifesaving medications go into shortage, the results can be fatal. Ensuring the continuity of the drug supply chain is therefore critical to public health. Quality issues, which can cause manufacturing lines to shut down or lose productivity, are cited as a primary contributor to shortages, but they are not the only forces at play. Read More

  • Pew Comments on FDA Draft Guidance Documents on Compounded Copies of Approved Drugs

    The Pew Charitable Trusts offered comments on draft guidance documents issued by the Food and Drug Administration in July 2016 regarding compounded drugs that are essentially copies of commercially available or approved drugs. The proposed guidance would preserve the FDA’s approval process, which is critical to protecting patient safety, while allowing important exceptions under limited,... Read More

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Tami Holzman

Officer, Communications

202.552.2122