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HHS Reverses Course on LDTs: COVID-19 LDTs Again Require FDA Premarket Review

USA - December 3 2021 On November 15, 2021, the U.S. Department of Health and Human Services (“HHS”) and the Food and Drug Administration (“FDA”) issued several policy…

Steven J. Gonzalez, Gregory H. Levine, Beth P. Weinman

Podcast: Non-binding Guidance: COVID-19 Vaccine Mandate Litigation

USA - July 29 2021 This installment of Ropes & Gray’s podcast series Non-binding Guidance explores the current legal challenges relating to vaccine mandates for public…

Megan Bisk, Gregory H. Levine

New SACHRP Recommendations on Interactions among Sponsors, Clinical Trial Sites, and Study Subjects

USA - May 5 2021 The U.S. Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (“SACHRP”) recently issued…

Mark Barnes

New European Data Protection Board (EDPB) Guidance Highlights - but Leaves Unresolved - Several GDPR Compliance Issues Facing Clinical Researchers

European Union - February 12 2021 Last week, the European Data Protection Board (the “EDPB”) released new guidance on the application of the European Union General Data Protection…

Michael DiMaio

New HHS Advisory Opinions Support Broad Application of PREP Act Immunity for COVID-19 Response

USA - November 3 2020 The United States Department of Health and Human Services ("HHS") Office of General Counsel ("OGC") recently issued two advisory opinions (20-03 and…

Gregory H. Levine, Joshua Oyster