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Do State Executive and Emergency Orders Offer Any Product Liability Protection Amidst the COVID-19 Outbreak?

USA - May 14 2020 As companies continue to produce, modify, and/or distribute essential medical equipment and supplies to support efforts to fight the COVID-19…

Bryan D. Pasciak, Jack Frost, Kaitlyn E. Stone, Tess M. Godhardt.

Dire Consequences: Avoiding Waiver in Pennsylvania Jury Selection

USA - April 29 2020 Practicing law at a socially appropriate distance has forced many litigators to broadly consider the value of face-to-face interaction—and what may…

Rebecca L. Trela.

Claims That Manufacturers of IV Saline Solution Caused Public Health Crisis Twice Dismissed as Insufficiently Plead by Illinois Federal Court

USA - April 21 2020 “In the age of COVID-19 and other public health challenges, supply levels in the medical industry occupy a prominent place in our national…

Kaitlyn E. Stone.

FDA Funding Opportunity Announcement: “Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional”

USA - April 3 2020 The U.S. Food & Drug Administration (FDA) has released a Funding Opportunity Announcement (FOA) titled “Exploring the use of Real-World Data to…

Erica Abshez Moran, 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.