Risk Evaluation and Mitigation Strategy (REMS) Public Meeting

Risk Evaluation and Mitigation Strategy (REMS) Public Meeting
The Food and Drug Administration (FDA) is announcing a 2-day public meeting to obtain input on issues and challenges associated with the development and implementation of risk evaluation and mitigation strategies (REMS) for drugs. As FDA has taken steps to implement the REMS provisions of the Federal Food, Drug, and Cosmetic Act (FDCA), some stakeholders have raised concerns about the impact of various REMS, and the growing number of REMS, on the healthcare system, as well as on individual prescribers, pharmacists, distributors, and other affected stakeholders. To obtain public comment about REMS for drugs and their impact, and to gather additional input on a draft guidance issued on October 1, 2009 entitled, “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications,” FDA has decided to hold this public meeting. FDA wishes to give a wide range of stakeholders the opportunity to provide comment in this area. FDA will take input from the meeting into account in its development of guidance regarding REMS for drugs.

Date(s): July 27-28, 2010

Time: 8:30 a.m. to 4:30 p.m.
Risk Evaluation and Mitigation Strategy (REMS) Public Meeting