Trends in the US Food and Drug Administration's Use of Class-wide REMS

摘要

President George W Bush signed the Food and Drug Administration Amendments Act into law on 27 September 2007, a day that people who work on drug regulatory issues celebrate or decry depending on their point of view.This landmark legislation amended the Federal Food, Drug, and Cosmetic 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 post-market safety of drugs and biologies by granting the FDA the authority to mandate labelling changes, post-market studies and Risk Evaluation and Mitigation Strategies.