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Risk Evaluation and Mitigation Strategy (REMS)

  • REMS in SPL Webinar1:03:44

    REMS in SPL Webinar

    SPL expert Gary Saner discusses the FDA's new initiative to receive Risk Evaluation and Mitigation Strategy (REMS) submissions in Structured Product Labeling format.

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  • 4 Reasons to Submit REMS in SPL Now

    4 Reasons to Submit REMS in SPL Now

    Some industry members may question whether REMS in SPL is worth the effort, since SPL is not yet mandated for REMS. Here are four great reasons to get start submitting REMS in SPL now.

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  • FDA now accepting REMS in SPL format

    FDA now accepting REMS in SPL format

    Submission of REMS in SPL will help to clarify and standardize REMS content across the industry, making FDA review procedures more efficient.

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