USA – FDA Finalizes Revised REMS Modifications Guidance

The US Food and Drug Administration (FDA) on Tuesday finalized a revision of its guidance on making and submitting modifications and revisions to risk evaluation and mitigation strategies (REMS).

Specifically, the guidance lays out FDA’s policies for REMS modifications and revisions, including what types of changes the agency will consider and the processes and procedures for submitting those changes to the agency.

The 26-page guidance finalizes an earlier version released for comment in April 2015 that included changes to the section covering submission procedures for REMS revisions in response to amendments to the Federal Food, Drug, and Cosmetic Act under the Food and Drug Administration Safety and Innovation Act (FDASIA).

Under the guidance, FDA explains that REMS revisions consist of editorial changes that do not affect the information in the REMS and materials covering serious risks or safe use of a product and do not change the actions stakeholders must take to comply with the REMS.

All other changes to a REMS are considered either minor or major modifications. According to the guidance, a minor modification may have a limited effect on the REMS information and materials, while changes that have a substantial effect on the REMS are considered major.

For instance, adding or removing a strength or dosage of a product due to an approval or withdrawal of approval would be considered a minor modification, while making changes to a REMS goal or adding new information about a serious risk of a drug would be considered a major modification…