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FDA Issues New Draft Guidance on “Least Burdensome” Principles for Medical Devices

USA - December 21 2017 On December 15, the U.S. Food & Drug Administration (FDA) issued “The Least Burdensome Provisions: Concept and Principles: Draft Guidance for Industry…

Michael C. Zogby.

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…

Katherine McBeth, Michael C. Zogby.

Third Circuit tackles third-party funding issues in in re: national Football League players’ concussion injury litigation

USA - June 10 2019 Third-party litigation funding has received increased scrutiny over the past several years, particularly in the context of mass torts, class actions…

Christian E. Piccolo.

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:…

Katherine McBeth, Michael C. Zogby.

Clinical Trial Activity Is Not an Exception to the Rule

USA - October 17 2018 Defendants and courts have seen a variety of arguments set forth in attempts to demonstrate specific personal jurisdiction. One argument seen with…

Christian E. Piccolo.