FDA/NIH INFORMED CONSENT REGS TO BE RECONCILED AT CONSENSUS WORKSHOP; EMERGENCY RESEARCH GUIDE NEEDS REVISION IN LIGHT OF TREATMENT ADVANCES -- FDAer
Executive Summary
FDA and the National Institutes of Health will try to reconcile their informed consent regulations at a workshop expected to be held sometime this fall for patients, physicians, ethicists and members of Institutional Review Boards, FDA Deputy Commissioner Mary Pendergast told a May 23 hearing of Rep. Wyden's (D-Ore.) House Small Business/Regulation Subcommittee.