Drug Safety Project

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  • Comments to FDA on 503B Quality Standards Draft Guidance

    On September 2, Pew submitted comments to the U.S. Food and Drug Administration in response to draft guidance on the implementation of Title I of the Drug Quality and Security Act. The comments highlight the need for more robust safeguards when compounding occurs on a larger scale and reference the Pew commissioned report “Ensuring the Safety of Compounded Drugs: Study highlights key... Read More

  • Pew and Partners Comment on FDA’s Suspect Product Guidance

    On Monday, August 11, The Pew Charitable Trusts submitted comments on draft guidance documents from the U.S. Food and Drug Administration on how supply chain partners will identify and notify other partners of “suspect product,” part of Title II of the Drug Quality and Security Act, Drug Supply Chain Security Act. Read More

  • Consumer and Drug Industry Representatives Back New Fees to Cover Inspections

    WASHINGTON – Allan Coukell, director of the Medical Safety Division of the Pew Health Group, issued the following statement today, commenting on a March 14-15 conference, "After Heparin: A Roundtable on Ensuring the Safety of the U.S. Drug Supply," in which industry and consumer experts called for changes to address the risk of counterfeit and substandard medicine: Read More

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