FDA publishes draft guidance on format and content of REMS document

Earlier this month the US Food and Drugs Administration (FDA) released draft guidance providing revision of previous advice on the format and content of risk mitigation strategy (REMS) document requirements for prescription drugs or biologics. 

The draft guidance document is a revision of the FDA guidance document (2009)  ‘Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications’. The FDA hopes that this revised guidance will result in future REMS documents that are more consistent in format and content, and are easily understood. The draft guidance document also contains an overview outlining the type of information that should be included in the REMS document and a template for the information is included in the appendices.

The FDA states that “This guidance does not provide detailed information on the format and content of other documents that are part of a REMS submission, such as the REMS materials or the REMS supporting document. Furthermore, the guidance does not include information on how to design, implement, or evaluate a REMS, and does not address submissions that are unique to shared system REMS,”

The FDA does not require applicants to apply for the conversion of existing REMS documents into the new format.

The full draft guidance document can be found here.