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Revised REMS Modification Guidance Finalized by FDA

09th July 2019

The US FDA finalized a revised guidance on making and submitting modifications and revisions to risk evaluation and mitigation strategies (REMS), including what types of changes FDA will consider and processes and procedures for submitting those changes to the FDA.

The changes are finalized in response to amendments to the Federal Food, Drug and Cosmetic Act under the Food and Drug Administration Safety and Innovation Act (FDASIA).

The changes in the revised REMS does not affect the REMS information, materials covering risks or safe use of a product and does not change actions needed to be taken of REMS compliance. All other changes to a REMS are either minor or major.

Revisions in REMS should be submitted as REMS Revision and documented in the next annual report.

For REMS modifications, the sponsors should submit minor modifications as a change being affected in 30 days (CBE-30) supplement and major modifications as a prior approval supplement (PAS).

The FDA will take 60 days to act on proposed minor modifications and 180 days for major modifications. The Drugmaker can only implement these changes after the FDA’s approval.

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