Draft Guidance Broadens Authority of IRBs for Continuing Reviews

January 21, 2010
To bolster its efforts to improve the quality of clinical research, the FDA for the first time in 12 years has formally blessed substantially broader power for IRBs in a new draft guidance. The draft changes the way an IRB may determine review dates and when it may give an expedited review, according to a Federal Register notice. Comments are due March 15.
Clinical Trials Advisor