Debra Norman, Ph.D., JD

On March 25, 2008, new legislation designated as the Food and Drug Administration Amendments Act of 2007 (FDAAA; "the Act") took effect, which directed FDA to develop a systematic, scientifically sound approach to managing the risk-benefit ratio of a drug throughout its lifecycle, with an explicit focus on postapproval safety. In September 2009, FDA announced a draft guidance to assist sponsors in the preparation of a REMS. The guidance provides links to a number of resources available at FDA to aid in REMS preparation.