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Massachusetts Court Upholds Temporary Ban on the Sale of All Vaping Products

USA - November 15 2019 While various states and municipalities grapple with how to address the proliferation of e-cigarette or vaping product use associated lung injury…

Kenneth A. Murphy.

FDA’s Final Guidance: “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions”

USA - September 26 2019 The U.S. Food & Drug Administration (FDA) has released a final guidance document entitled, “Consideration of Uncertainty in Making Benefit-Risk…

Chanda A. Miller, Michael C. Zogby.

FDA Final Guidance Document “Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry”

USA - August 15 2019 On July 9, 2019, the U.S. Food & Drug Administration (FDA) released the final guidance document “Risk Evaluation and Mitigation Strategies:…

Chanda A. Miller, Michael C. Zogby.

District of Delaware Grants Motions for Summary Judgment in Three Risperdal Gynecomastia Cases

USA - June 19 2019 In a trio of recent decisions arising out of cases alleging that an antipsychotic medication, Risperdal, and its generic, risperidone, had caused…

William V. Essig.