WASHINGTON, Dec. 16 -- Food and Drug Administration has issued a notice called: Investigator Responsibilities-Safety Reporting for Investigational Drugs and Devices; Guidance for Investigators, Industry, and Institutional Review Boards; Availability.
The notice was published in the Federal Register on Dec. 16 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for investigators, industry, and institutional review boards (IRBs) entitled "Investigator Responsibilities-Safety Reporting for Investigational Drugs and Devices." The guidance is intended to help clinical investigators compl...