As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although there was no single moment like the passage of the Affordable Care Act in 2010, there are numerous distinct events that will loom large in 2024 and beyond.Continue Reading 2024 Top-of-Mind Issues for Life Sciences Companies
Keren Baruch is an associate in the Corporate Practice Group in the firm's New York office.
Connecticut is the latest state to join the efforts of jurisdictions such as Oregon, Nevada, Washington D.C., and the City of Chicago, Illinois, in further regulating the activities of pharmaceutical representatives. In June, Governor Ned Lamont signed into law “An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs” (the “Act”), which imposes new registration, reporting, and disclosure requirements on pharmaceutical representatives in the State of Connecticut. The Act builds on Governor Lamont’s policy initiatives, which aim to improve the delivery of care and reduce healthcare costs for Connecticut residents and includes the initiative to regulate pharmaceutical marketing practices. The Act sets forth certain requirements for pharmaceutical manufacturers and “pharmaceutical representative(s)” which remain subject to further clarification based on any forthcoming guidance and regulations from the Connecticut Department of Consumer Protection (“CT DCP”).Continue Reading Connecticut Follows in the Footsteps of Other Jurisdictions Requiring Registration of Pharmaceutical Representatives
This week, FDA Commissioner Stephen M. Hahn, M.D., along with Dr. Anthony S. Fauci, M.D., of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, and officials from the Centers for Disease Control and Prevention and U.S. Department of Health and Human Services testified on Capitol Hill on the federal response to COVID-19, including the latest on vaccine development and facility inspections. FDA also issued an updated guidance on conducting clinical trials during COVID-19, showing its willingness to continue to adapt its policies to facilitate remote patient access during COVID-19.
Continue Reading FDA Update: The Latest on Vaccine Development, Inspections, and Conducting Clinical Trials During Covid-19