In the October 6, 2015, Federal Register, FDA announced the beginning of a pilot project for the submission of final approved Risk Evaluation and Mitigation Strategies ("REMS") and certain REMS summary information electronically in a standard Structured Product Labeling ("SPL") format. The pilot is intended to help application holders, FDA, and other interested stakeholders evaluate a potential approach to converting REMS into SPL format and evaluate the usefulness of the REMS information to be provided in SPL format. Requests to participate due December 7, 2015.
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