FDA: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications

This guidance applies to certain drug and biological products submitted for approval or approved under sections 505(b) or 505(j) of the Federal Food, Drug, and Cosmetic Act (FDCA), or section 351 of the Public Health Service Act (PHS Act), that are required by FDA to have a REMS. The information on the content of a proposed REMS submission (section III of this document) also applies to proposed REMS that are voluntarily submitted by applicants or holders of approved applications (see section II.A of this document).