REMS Document Technical Conformance Guide provides updated, detailed instructions on the format of a REMS Document, along with standardized language that describes common REMS requirements for applicants to use whenever possible, to help ensure consistency and facilitate efficient review of the REMS Document. This Guide supports submission of a REMS Document in Structured Product Labeling (SPL) format. In addition, this Guide provides an outline to assist applicants in drafting a Bifurcated REMS Document.
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