Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period

Résumé

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 and biological products. 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 health care system, as well as on individual prescribers, pharmacists, distributors, and other affected stakeholders. To obtain public input about the REMS program and its impact, and to gather additional input on a draft guidance for industry issued on October 1, 2009 entitled "Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and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 input in this area, and will take the information it obtains from the meeting into account in its implementation of the REMS program and in the development of the final guidance and future REMS