Healthcare & Pharmaceuticals Blog
- Blog: Haynes and Boone BlogsClass Action Case Certified for Failure to Provide COBRA Election Notices in SpanishPosted on August 15, 2018 by Haynes and Boone Benefits GroupA U.S. District Court in the 11th Circuit certified as a class action a case in which the plaintiff argued that her former employer, the Marriott International hotel chain, violated federal law by failing to: (1) provide a COBRA notice in Spanish; (2) adequately explain the procedures to elect healthcare coverage; (3) identify itself as […] The post Class Action Case Certified for Failure to Provide COBRA Election Notices in Spanish appeared first on Haynes and Boone Blogs.
- Blog: Waller Law BlogWhy QAPI spells success for skilled nursing facilitiesPosted on August 15, 2018 by Jeffery D. Parrish
- Blog: Biologics BlogFDA Approves First-Ever siRNA TherapyPosted on August 9, 2018 by Today FDA approved the first-ever “small interfering RNA” (siRNA) product, marking a significant milestone in the story of RNA interference (RNAi) technology and clearing the way for a new type of therapeutic. Alnylam® secured approval and Orphan Drug Designation for its siRNA product Onpattro (patisiran), a therapy for the rare hereditary disease transthyretin-mediated amyloidosis in adult [...]
- Blog: EndpointsFormer FDA Counsel Joins Verrill Dana’s Health Care GroupPosted on July 16, 2018 by Academic and Clinical Research GroupWe are pleased to welcome attorney Katlin McKelvie Backfield to our nationally recognized Health Care Group. Katlin comes to Verrill Dana with more than 15 years of pharmaceutical regulatory experience, including more than a decade at the Food and Drug Administration. While at the FDA, Katlin served as Associate Chief Counsel for Drugs in the Office of Chief Counsel and as a Regulatory Counsel in the Division of Drug Marketing, Advertising, and Communications (DDMAC) (now the Office of Prescription Drug Promotion). Prior to joining [...]