FDA’s 2002 Regulatory Agenda, In Brief

Executive Summary

IRB registration: FDA to propose rule requiring institutional review boards to register with the agency. Registration information would include name of institution operating the IRB, detailed contact information for "the senior officer of the institution and IRB chair or contact, the range of active protocols...involving FDA-regulated products reviewed in previous calendar year, and a description of the types of...products reviewed." The rule is intended to "make it easier for FDA to inspect IRBs and to convey information to IRBs," HHS' Unified Agenda for 2002 explains. FDA is also endorsing a voluntary IRB accreditation system...