Fda Includes Rems Guidancein Final Drug Safety 5-year Plan

摘要

The FDA now plans to develop and publish a guidance or evaluation and mitigation strategies (REMS) and safety labelir cording to revisions in its final five-year drug safety plan.rnThe final plan is almost identical to a draft released last March but has three revealing additions (WDL, April 7, 2008). The final plan says FDA will issue a guidance on REMS and safety labeling that was not mentioned in either the draft version or CDER's agenda for developing guidances in 2009.