News: Finalization on revised REMS Modifications Guidance is here
The Food and Drug Administration (FDA) declared finalization on the revised REMS Modification Guidance. The revised guidance discusses the modification and revisions to Risk Evaluation and Mitigation Strategies (REMS). It also lays out an updated policy on the type of changes the agency can carry out and also the procedures for the submission of these changes.
The earlier version was a 26 paged guidance and was released back in April of 2015. The guidance covered the response to the amendments to the Federal Food and Cosmetic Act under the Food and Drug Administration Safety and Innovation Act (FDASIA). The guidance marks the changes that don't change the information regarding the risks of the products in the REMS and the stakeholder's actions that should not change and must be in compliance with REMS.