FINAL FDA CME POLICY ALLOWS GENERAL STATEMENT ON OFF-LABEL USES INSTEAD OF DISCLOSURE FOR EACH UNAPPROVED USE DISCUSSED; WRITTEN CONTRACTS DEEMPHASIZED
This article was originally published in The Gray Sheet
Executive Summary
FDA will consider a general statement on unapproved device uses during continuing medical education programs as sufficient disclosure under the agency's final "Guidance for Industry: Industry-Supported Scientific and Educational Activities" released Dec. 3.