2. Summary of the Benefit and Risk Assessment

This section of the document should include a description of the evidence used in the assessment of the effects of the REMS on the risks and benefits associated with the drug.

3. Regulatory Actions and Rationale

a. Regulatory Decision

This section should include a statement of the regulatory decisions considered to respond to the public health question.

b. Rationale

This section should discuss the rationale for the regulatory decision, including a description of any factors other than the benefit and risk assessment that might have affected the decision, such as ethical issues, patient perspectives, timeframe issues, the lack of an available treatment for a disease, and the risk posed by the drug in a specific population.

c. Concomitant Actions

If the removal of a REMS requirement is the only regulatory action considered and taken at this time, this section should indicate that no other regulatory actions were considered and taken at this time.

4. Schedule of Future Reviews

This section should include a schedule of future evaluations of the benefit–risk profile, taking into account when additional information on the benefits or risks associated with the drug is expected. This section should also outline any plans to review the decision, and the decision-making process used for the drug. For example, if the approval of Drug X was controversial or difficult, this section should include a schedule for reviewing the affect of the decision on the public’s health, and reviewing the process used for the decision to identify ways to improve the decision-making process in the future.



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