Trends in FDA’s Use of Class-wide REMS
Posted 01 December 2009 | By
President George W. Bush signed the Food and Drug Administration Amendments Act (FDAAA) into law on 27 September 2007, a day that people who work on drug regulatory issues celebrate or decry depending upon their point of view. This landmark legislation amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act. Of the 11 titles that comprise FDAAA, Title IX is the most far reaching, with provisions intended to improve the postmarket safety of drugs and biologics by granting the US Food and Drug Administration (FDA) the authority to mandate labeling changes, postmarket studies and Risk Evaluation and Mitigation Strategies (REMS).