David Peloquin
Ropes & Gray LLP
Articles
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…
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…
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…
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…
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…
