Update on USFDA Draft Guidance on REMS

Update on format and content of a REMS document – Revision of the 2009 Guidance

This guidance provides updated recommendations for the format and content of a risk evaluation and mitigation strategy (REMS) document for a prescription drug product, including a biological drug product.

A REMS document, which is part of a REMS that is required by FDA, establishes the goals and requirements of the REMS. This guidance provides recommendations to applicants on drafting proposed REMS documents and converting an already-approved REMS document to a new, standardized format that is clearer, more informative, and supports submission of a REMS document in Structured Product Labeling (SPL) format. FDA does not expect applicants of an approved product subject to a REMS to submit a proposed REMS modification solely to convert their REMS document to the new format. Changing the REMS document to the new format should be done in conjunction with other REMS modifications.

This guidance provides an overview of the types of information that should be included in a REMS document. Additional and more detailed information is provided in the template appended to this guidance, which is also available on FDA’s Web site.

This guidance and the appended template are intended to help ensure that REMS documents are clear, understandable to stakeholders, and to the extent possible, consistent in content and format.

Comments are invited during a 60 days period.

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