The US Food and Drug Administration (“FDA”) recently issued a Manual of Policies and Procedures (“MAPP”) describing how the Center for Drug Evaluation and Research (“CDER”) evaluates Risk Evaluation and Mitigation Strategy (“REMS”) submissions, as well as policies and responsibilities pertaining to that review.
REMS Assessment Reviews are conducted by the Office of Surveillance and Epidemiology (“OSE”) Division of Risk Management (“DRM”), in conjunction with representatives of the Office of New Drugs (“OND”), Office of Generic Drugs (“OGD”), Office of Compliance and other relevant CDER offices. The review is typically completed no later than 180 days from receipt of the REMS submission.
The review will be conducted according to the following steps:
- Initiation of REMS Assessment Report Review: OSE notifies DRM when a REMS Assessment Report is submitted to the agency. DRM then “triages” the report to determine if it is complete and whether it is acceptable for review. If so, DRM assigns relevant staff to the review.
- Review of REMS Assessment Report: To complete the review, DRM drafts review materials and meeting slides which incorporate key findings, preliminary conclusions and recommendations for discussion at the review team meeting. DRM also identifies specific issues that need discussion or input.
- Discussion of review finding with REMS Assessment Review Team: The team makes determinations as to if the REMS Assessment Report is complete, if the REMS is meeting its risk mitigation goals, if the REMS requires modification, and if the REMS assessment plan requires revisions. The discussion, recommendations and conclusions are then incorporated into the DRM review.
- Completion of REMS Assessment Review: The final DRM REMS Assessment Review is cleared by the DRM director and then by OND.
- Communication of Conclusions and Comments to Applicant(s): The OND and OGD drafts language for the REMS Assessment Letter, which is then reviewed by DRM. The OND then clears and signs the REMS Assessment Letter for New Drug Application (“NDA”) and Biologic License Applications (“BLA”) applicants. In the case of Abbreviated New Drug Applications (“ANDA”) applicants, the OGD clears and signs the letter.
The MAPP also discusses background information on when REMS are required, and what REMS may include for NDAs and BLAs, as well as timetables for submission. Finally, the MAPP describes in detail the various FDA offices that review and approve the REMS submissions, as well as their respective functions. The MAPP became effective on December 18, 2019.