• Federal Preemption of State Pharmaceutical Product Liability Tort Law: The FDA Speaks Out
  • January 23, 2006 | Author: Glenn M. Farnet
  • Law Firm: Kean Miller Hawthorne D'Armond McCowan & Jarman, L.L.P. - Baton Rouge Office
  • The U.S. Food and Drug Administration (FDA) announced on January 18, 2006 that it is issuing final regulations making a "major revision" to the format of prescription drug information. Among other things, the rule revises the current regulations to require that the prescribing information of new and recently approved products includes "Highlights" of the prescribing information and a table of contents for the full prescribing information.